Biologic Specimen and Data Repository Information Coordinating Center

ACCESS examined the etiology of sarcoidosis, as well as socioeconomic variables and the clinical course of patients with sarcoidosis, including quality of life.

CHAT evaluated the efficacy of early adenotonsillectomy versus watchful waiting with supportive care, with respect to cognitive, behavioral, quality-of-life, and sleep factors in children with the obstructive sleep apnea syndrome.

ACCORD investigated if intensive glycemic control, multiple lipid management, and intensive blood pressure control could prevent major cardiovascular events in adults with type 2 diabetes mellitus. The EYE and MIND sub-studies additionally evaluated the interventions' effects on the progression of diabetic retinopathy and the brain (cognition and structure), respectively. The ACCORDION follow-up study examined the long-term effects of the ACCORD treatment strategies.

ACT compared the effects on cardiorespiratory fitness of two physical activity counseling interventions with current recommended care in a primary care setting. The advice (control) group received physician advice based on national recommendations, the assistance group received the same advice and educational materials plus a counseling session, while the counseling group additionally received telephone based counseling at selected intervals.

ACS-QUIK assessed the implementation and effect of a locally-developed quality improvement toolkit on 30-day major adverse cardiovascular events for patients with acute coronary syndrome in Kerala, India.

ATTRACT was designed to determine whether pharmacomechanical thrombolysis prevents post-thrombotic syndrome in patients with proximal deep-vein thrombosis.

AADR characterized the clinical and laboratory course of patients with severe alpha 1-antitrypsin deficiency whether or not the patient is undergoing long-term augmentation therapy.

PACTG was a controlled Phase III trial designed to determine if HIVIG given to HIV-positive pregnant women during the second and third trimester of pregnancy reduced the likelihood of maternal-fetal HIV transmission.

AVID evaluated whether the use of an implantable cardiac defibrillator results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from arrhythmic causes.

The Hypertension Study component investigated whether treatment with a calcium channel blocker or an angiotensin-converting enzyme inhibitor lowers the incidence of CHD or other CVD events vs. treatment with a diuretic. The Lipid Study component assessed whether pravastatin compared with usual care reduces all-cause mortality in older, moderately hypercholesterolemic, hypertensive participants with at least one additional CHD risk factor.

AMIS tested whether the regular administration of aspirin to adults who had experienced at least one documented myocardial infarction would result in a significant reduction in total mortality over a three-year period.

ACIP investigated three treatment strategies for asymptomatic cardiac ischemia: angina-guided medical strategy, angina-guided plus AECG ischemia-guided medical strategy, and revascularization by angioplasty or bypass surgery.

The main objectives of ARIC are to 1) investigate associations of factors with prevalence of atherosclerosis and incidence of CHD, clinical stroke and other CVD; and 2) measure CVD occurrence and trends and relate these to community levels of, and changes in, risk factors, medical care and atherosclerosis. Data from the first eight examination cycles, annual follow-up for years 2-32, events through 2019, and select ancillary studies are available.

AIM-HIGH tested the hypothesis that patients with atherosclerotic CVD optimally treated on a statin but with residual atherogenic dyslipidemia would benefit from the addition of extended release niacin with fewer cardiovascular events.

AFFIRM compared total mortality between two treatment strategies for atrial fibrillation: maintenance of sinus rhythm, or ventricular response rate control.

The BEST-CLI trial was initiated to determine whether endovascular revascularization was superior to surgical revascularization in patients with chronic limb-threatening ischemia.

BEST evaluated whether bucindolol hydrochloride, a nonselective beta-adrenergic blocker and mild vasodilator, would reduce the rate of death among patients with advanced heart failure, and to assess its effects in various demographic subgroups.

BHAT tested whether the regular administration of propranolol hydrochloride to adults who had experienced at least one myocardial infarction would result in a significant reduction in total mortality during a two- to four-year period.

BHS investigated the early natural history of CVD in a cohort of children and young adults in a biracial, semirural community.

BRIDGE sought to determine if bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure.

BEST-COPD aimed to establish a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2 for development as a potential novel treatment for patients with COPD.

BARI compared survival in patients with multivessel disease and severe angina or ischemia randomized to receive either percutaneous transluminal coronary balloon angioplasty or coronary artery bypass grafting.

BARI 2D evaluated two cardiac treatment strategies (prompt revascularization vs. medical therapy alone) and two glycemic treatment strategies (insulin sensitization vs. insulin provision) in patients with coronary artery disease and diabetes.

CAST investigated the efficacy and safety of arrhythmia suppression therapy in patients with asymptomatic or mildly symptomatic ventricular arrhythmia after myocardial infarction.

The goals of CHS were to examine the extent to which known risk factors predict CHD and stroke in the elderly, assess the precipitants of CHD and stroke in the elderly, and identify the predictors of mortality and functional impairments in clinical CHD or stroke.

CORAL compared the incidence of cardiovascular and renal adverse events for medical therapy alone with medical therapy plus renal-artery stenting in patients with atherosclerotic renal-artery stenosis and elevated blood pressure, chronic kidney disease, or both.

The CABANA study was initiated to determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in patients with symptomatic atrial fibrillation.

CAMP evaluated whether continuous, long-term treatment with either an inhaled corticosteroid or an inhaled noncorticosteroid drug safely produces an improvement in lung growth as compared with treatment for symptoms only. The three continuation studies extended follow-up of the clinical trial cohort for an additional 4.5, 3.75, and 4 years respectively to observe asthma progression.

The COPTR consortium ran 4 independent trials. NET-Works was designed to evaluate a multicomponent obesity prevention intervention among diverse, low-income preschoolers. GROW was designed to test the effect of a multicomponent behavioral intervention on child BMI growth trajectories among preschool-age children at risk for obesity. IMPACT was designed to evaluate the effects of two family-based obesity management interventions on BMI in low-income children who were overweight or obese. Stanford GOALS was designed to test the effects of a community-based, multi-component, multi-level, multi-setting approach for treating overweight and obese children.

CHOICES examined the effectiveness of a 24-month weight gain prevention intervention to positively affect body mass index (BMI) in 2-year college students.

COAG tested whether genotype-guided dosing of warfarin improves anticoagulation control during the first 4 weeks of therapy when compared to clinical-guided dosing.

CLEVER compared the effectiveness of aortic stent surgery versus exercise therapy in individuals with aortoiliac insufficiency.

IPPB evaluated the efficacy of long-term intermittent positive pressure breathing treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease as compared to use of a powered nebulizer.

The COLCORONA study aimed to investigate the effect of colchicine on the composite of COVID-19-related death or hospital admission in community-treated patients.

Using a physician/pharmacist collaborative management (PPCM) approach to patient care, CAPTION investigated if blood pressure control of ethnically diverse and geographically distributed populations, could be better managed. In an asthma sub-study, researchers also investigated if using a PPCM approach could reduce the number of emergency department visits and hospitalizations.

CSSCD examined the natural history of sickle cell disease from birth to death in order to identify factors contributing to the morbidity and mortality of the disease. Biospecimens from adult subjects who attended the 2A follow-up study are available for request. Phase 2A of the study examined the progression of organ damage in the heart, lung, kidney and liver in adult cohort patients enrolled in phase 1 of the study.

COBLT investigated if banked unrelated donor umbilical cord blood could serve as an adequate hematopoietic stem cell source for adults and children with malignancies, immune deficiencies, inherited marrow failure, or inborn errors of metabolism.

CARDIA was designed to increase understanding of contributors to changes in CVD risk factors during the critical years of transition from young adulthood to middle age.

CASS included a randomized trial component and a registry of patients undergoing angiography. The primary objective of the registry was to provide information regarding the effects of coronary artery surgery on patients with ischemic heart disease within the clinical course of treatment. The randomized component investigated the short and long term effects of surgical versus medical interventions in patients with a reduced ejection fraction and significant coronary artery disease.

The main objective of the Coronary Drug Project was to test efficacy and safety of several lipid-influencing drugs in the long-term therapy of coronary heart disease in men who had a previous myocardial infarction.

The CHIVES study tested whether food vouchers redeemable only for fruit and vegetable purchases would improve fruit and vegetable consumption more than vouchers redeemable for any food and whether food vouchers redeemable only in one-week increments would improve fruit and vegetable consumption more than vouchers redeemable in monthly increments.

The overarching goals of the Center for International Blood and Marrow Transplant Research registry are to study trends in transplantations and to advance the understanding and application of allogeneic hematopoietic cell transplantation for malignant and non-malignant diseases.

The goal of the study is to generate a Sickle Cell Disease peripheral blood stem cell repository. Volunteer sickle cell disease patients were mobilized with plerixafor and peripheral blood stem cells were collected by apheresis.

PLADO was designed to evaluate the effect of prophylactic platelet transfusion dose on bleeding in patients with hypoproliferative thrombocytopenia.

DASH tested the effects of dietary patterns characterized by high intakes of certain minerals and fiber associated with low blood pressure compared with each other and with a control dietary pattern mirroring US consumption.

As a follow-up to DASH, DASH-Sodium tested the effects of two dietary patterns and three sodium intake levels on blood pressure in pre-hypertensive and stage 1 hypertensive adults.

The DELTA Study was initiated to evaluate the effects of the type and amount of dietary fat on lipids, lipoproteins, and hemostatic factors in healthy individuals as well as individuals at high risk of cardiovascular diseases.

DISC evaluated the efficacy and safety of a lipid lowering diet in 8 to 10 year old children with elevated LDL cholesterol after at least 3 years of follow-up.

The DISC06 follow-up study examined the long-term effects of an intervention to lower fat intake among adolescent girls on biomarkers that are related to breast cancer risk in adults.

DIG assessed the effect of increasing age on mortality, hospitalizations, and digoxin side effects in patients with heart failure, as well as whether the effect of digoxin on clinical outcomes varies as a function of age.

CPAP evaluated whether 12 weeks of nocturnal CPAP use would decrease the concentration of methacholine necessary to reduce FEV1 by 20% (PC20) in asthma patients.

EPIC investigated the efficacy and safety of four antipseudomonal treatments in children with cystic fibrosis with recently acquired Pseudomonas aeruginosa infection.

e-Moms Roc aimed to expand the understanding of how to slow the accumulation of weight in childbearing women by developing, implementing, and evaluating electronically mediated patient intervention programs for pregnant and postpartum women.

The objective of ENRICHD was to determine whether mortality and recurrent infarction are reduced by treatment of depression and low perceived social support with cognitive behavior therapy, supplemented with an SSRI antidepressant when indicated, in patients enrolled within 28 days after myocardial infarction.

ESCAPE tested whether pulmonary artery catheter use was safe and could improve clinical outcomes in patients hospitalized with recurrent heart failure.

FHS-OS enrolled offspring of the original cohort. Starting in 1994, the OMNI 1 cohort enrolled a new group of participants to reflect the ethnic diversity of the Framingham community. Data from the first 9 clinical exams, selected ancillary studies, event follow-up through 2017, and the first 4 exams from the OMNI 1 cohort are available.

FHS-Gen III enrolled adults with at least one parent enrolled in the Offspring study. The New Offspring Cohort enrolled spouses of Offspring participants that were not otherwise enrolled and had at least two biological children participating in Gen III. The OMNI 2 cohort enrolled additional ethnically diverse participants, including individuals related to OMNI 1 participants. Data from the first 2 clinical exams, selected ancillary studies, and event follow-up through 2018 are available.

FHS is an ongoing, prospective effort to study the incidence and prevalence of CVD and its risk factors, trends in CVD incidence and its risk factors over time, and familial patterns of CVD and risk factors. The study randomly sampled 2/3 of the adult population of Framingham, Massachusetts and continues to examine participants every two years. Data from the first 32 clinical exams, selected ancillary studies, and event follow-up through 2017 are available.

FOCUS tested the hypothesis that a higher threshold for blood transfusion would improve functional recovery and reduce morbidity and mortality, as compared with a more restrictive transfusion strategy.

GUIDE-IT was designed to determine whether an NT-pro-BNP-guided treatment strategy improves clinical outcomes compared to usual care in high-risk patients with heart failure and reduced ejection fraction.

HCS examined the relationships between characteristics of community programs and policies in preventing childhood obesity.

HF-ACTION examined whether exercise training reduces a composite endpoint of all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms.

HHL included two concurrent interventional studies. The primary goal of the High Blood Pressure study was to investigate ways to better control hypertension and reduce blood pressure disparities between African Americans and Caucasians. The Lifestyle Change study aimed to reduce risks associated with CVD by using behavioral modification techniques.

HEIRS evaluated the prevalence, genetic, and environmental determinants and potential clinical, personal, and societal impact of iron overload and hereditary hemochromatosis in adults.

HIT-RADIO was a retrospective analysis of positive heparin-PF4 antibody subjects to determine the time to occurrence of a composite triple endpoint of death, limb amputation/gangrene, and new thrombosis.

HIFI evaluated the hypothesis that high frequency oscillatory ventilation in preterm infants would reduce the incidence of mortality and pulmonary complications compared to conventional mechanical ventilation.

HCHS-SOL is an ongoing study that aims to describe the prevalence of major CVD risk factors and CVD among US Hispanic/Latino individuals, examine the relationships of socioeconomic status and acculturation with CVD risk profiles and CVD, and assess cross-sectional associations of CVD risk factors with CVD. Additional data are available from the SOLNAS, SUENO, Sociocultural, and Youth ancillary studies.

HHP investigated environmental and biological causes of morbidity and mortality from CHD and stoke among Japanese Americans living in Honolulu in comparison to other populations.

BABY HUG consists of a randomized controlled trial and two observational follow-up studies. The trial found that hydroxyurea can be considered safe and effective for all very young children with sickle cell anemia.

HDFP was designed to test the efficacy of antihypertensive therapy in reducing all-cause mortality in a population-based study.

ICARE evaluated whether a centralized, remote, clinical pharmacy service could improve guideline adherence and secondary measures of cardiovascular risk in primary care offices in rural and small communities.

The ICU-RESUS study evaluated if a bundled intervention comprising physiologically focused CPR training at the point of care and structured clinical event debriefings, compared with usual care, improves outcomes in children that experience in-hospital cardiac arrest.

The iCOMPARE trial aimed to compare all-cause mortality of patients cared for by trainees in internal-medicine residency programs with either standard duty hours or flexible duty hours. The Time and Motion substudy additionally aimed to determine the amount of time trainees spend on direct patient care and education. The Sleep and Alertness substudy aimed to determine the sleepiness of trainees.

IDEA tested the hypothesis that, compared with a standard behavioral weight loss intervention, a technology-enhanced intervention would result in greater weight loss.

Intermacs and Pedimacs are North American data registries of adults and children who received an FDA approved mechanical circulatory support device (MCSD) due to advanced heart failure, with the goal of advancing the understanding and application of MCSDs in order to improve the patient's duration and quality of life. Data from the Medical Arm of Mechanical Circulatory Support (MedaMACS) Study is also available.

The ISCHEMIA trial and ISCHEMIA-CKD trials were initiated to determine whether an initial invasive strategy of cardiac catheterization and optimal revascularization, if feasible, in addition to optimal medical therapy, will reduce major adverse cardiovascular events compared with an initial conservative strategy of optimal medical therapy alone. Participants in ISCHEMIA had stable ischemic heart disease and moderate or severe ischemia, participants in ISCHEMIA-CKD also had advanced kidney disease.

LRC-CPPT tested the efficacy of cholesterol lowering in reducing risk of CHD and examined evidence for a causal role of these lipids in the pathogenesis of CHD.

LRC-PS conducted a standardized series of cross-sectional surveys to determine the prevalence of dyslipidemias and describe the distributions of lipids and lipoproteins in major ethnic and social groups. The Family Study portion was designed to obtain knowledge of the distribution of lipids and lipoproteins among family members and of the association of familial and genetic attributes to dyslipoproteinemias.

LOTT evaluated the efficacy of long-term treatment with supplemental oxygen in patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation.

Lung HIV was an initiative established to expedite the data and specimen collection results of eight different HIV and pulmonary studies operated under NHLBI. The project used these existing studies to create a foundation for future research and provide further insight on the relationship between pulmonary disease and HIV infection.

LHS examined the effects of Special Care, compared to Usual Care, on rate of decline in pulmonary function in cigarette smokers. Additionally, the study examined if participants with chronic obstructive pulmonary disease (COPD), who were assigned to inhaled corticosteroids had a lower rate of decline in lung function and lower incidence of respiratory morbidity. The study also evaluated the long-term effects of smoking cessation and continued smoking in subjects with early COPD.

The LTRC was a biobank resource that collected lung tissue, blood samples, clinical data, and radiographic studies from participants with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other related idiopathic interstitial pneumonias and interstitial pneumonias associated with connective tissue diseases who undergo medically-indicated lung resection.

The MEDFOCUS study aimed to evaluate whether a centralized, web-based cardiovascular risk service managed by clinical pharmacists would improve guideline adherence in multiple primary care medical offices with diverse geographic and patient characteristics.

MAGIC examined whether early intravenous magnesium treatment of patients with suspected acute myocardial infarction would reduce mortality.

MESA is an ongoing epidemiological study that is investigating the prevalence, correlates, and progression of subclinical CVD and risk factors that predict progression to clinically overt CVD or progression of subclinical disease itself. Data from exams 1-5, events though follow-up year 10, and eleven ancillary studies are available

MHCS-I evaluated and prospectively followed patients with hemophilia or a related coagulation disorder in order to understand the cause and natural history of HIV infection and AIDS in this population which was at high risk for development of AIDS. MHCS-II evaluated and prospectively followed a cohort of subjects with hemophilia who were exposed to hepatitis C virus in order to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma, evaluate causal markers, identify predictive markers, identify genes that confer susceptibility or resistance, and identify response and complication rates of anti-HCV and anti-HIV treatment regimens.

MSH evaluated whether or not treatment with hydroxyurea titrated to maximum tolerated doses would reduce the frequency of vaso-occlusive (painful) crises by at least 50%. This controlled trial made hydroxyurea the first drug of proven benefit in the prevention of vaso-occlusive pain crisis and acute chest syndrome caused by sickle cell disease.

MRFIT investigated the effect of multiple risk factor intervention on mortality from CHD in high risk men. The intervention group received nutrient intake guidelines, cigarette cessation aids, and hypertension management.

NGHS assessed racial differences in dietary, physical activity, family, and psychosocial factors associated with the development of obesity from pre-adolescence through maturation between African-American and Caucasian girls. Secondarily, NGHS examined the effects of obesity on CVD risk factors.

CBB specimens were collected under the Cord Blood Transplantation Study Cord Blood Banking program with the objective of building an ethnically diverse unrelated cord blood bank and developing standard operating procedures for umbilical cord blood donor recruitment, selection and banking.

NETT compared lung-volume-reduction surgery with medical therapy for severe emphysema, and identified patient selection criteria for lung volume reduction surgery. The current release of the NETT study dataset includes follow-up data through May of 2013.

NLMS was designed to investigate social, economic, demographic and occupational differentials in mortality (total and by cause) within a national sample of the U.S. population.

The overall objective of GenTAC was to establish a registry of patients with genetically induced thoracic aortic aneurysms and related cardiovascular conditions, and collect associated medical data, as well as blood and tissue samples and make them available to investigators to advance research in diagnosis and management of genetically induced thoracic aortic aneurysms.

NANB-TAH was an extended follow-up study of 5 major prospective studies of transfusion-associated hepatitis that attempted to address the uncertainty about the frequency progression to clinically symptomatic and debilitating chronic liver disease and the frequency of fatal liver disease. The study, designed to track both mortality and morbidity of transfusion-associated non-A, non-B hepatitis, was a natural history evaluation that began at the time of disease onset and monitored subjects for almost 25 years.

MASM measured activity data in subjects with sleep disorders or restless leg syndrome in order to define an object oriented data model for large activity datasets and patient level data, and apply existing and new advanced statistical and visualization methods for activity data.

H1N1 aimed to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.

OAT tested the hypothesis that opening an occluded infarct artery 3-28 days after an acute myocardial infarction in stable patients who are at increased long-term risk would reduce mortality, recurrent MI, and congestive heart failure.

OMNI Heart compared the effects of three healthy diets, each with reduced saturated fat intake, on blood pressure and serum lipids in adults with pre-hypertension or stage 1 hypertension.

STOP II evaluated whether prophylactic transfusion in patients with sickle cell disease and a high risk of stroke can be safely halted after 30 months of treatment during which patients became low risk for stroke.

PREMIER compared the effects on blood pressure of two multi-component behavioral interventions and an advice only group over a period of 18 months. The two behavioral interventions promoted established recommendations that reduce blood pressure and one intervention additionally promoted the DASH diet.

PRIDE was composed of six diversity-focused, mentored-research education programs for early-career investigators engaged in heart, lung, blood, and sleep research.

The PPH Registry evaluated the natural history, etiology, pathogenesis and treatment of primary pulmonary hypertension.

P2C2 aimed to determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.

CABG examined the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously

POWER-UP tested the effectiveness of three primary care practice behavioral interventions in reducing weight. The primary aim was to show that both brief and enhanced brief lifestyle counseling would result in significantly greater weight loss at 24 months than would usual care.

PROP aimed to identify suitable predictors of respiratory outcomes that may serve as surrogate endpoints in future trials of prevention and therapy of respiratory diseases in preterm infants.

PATHS examined whether blood pressure is reduced for at least 6 months with an intervention to lower alcohol intake in moderate to heavy drinkers with above optimal to slightly elevated diastolic blood pressure, and whether reduction of alcohol intake can be maintained for 2 years.

PEACE tested the hypothesis that patients with stable coronary artery disease and normal or slightly reduced left ventricular function derive therapeutic benefit from the addition of ACE inhibitors to conventional therapy.

PIOPED examined the sensitivities and specificities of ventilation/perfusion lung scans for acute pulmonary embolism.

PROMISE compared health outcomes in patients presenting with new symptoms suggestive of coronary artery disease that were evaluated using anatomical testing via coronary computed tomographic angiography, as compared to functional testing.

PF-ILD Proteomics was initiated to identify novel plasma biomarkers of progressive fibrosing interstitial lung disease and develop a proteomic signature to predict this phenotype.

PIMI investigated psychophysiological factors related to both symptomatic and asymptomatic cardiac ischemia.

PAD evaluated the broad implementation of Public Access Defibrillators in urban community units. The main outcome measure was survival to hospital discharge of patients with out-of-hospital cardiac arrest.

PRHHP investigated morbidity and mortality from CHD in Puerto Rican rural and urban men. The objectives included identifying factors related to the development of CHD, comparing the etiology of disease in rural versus urban men, and determining the prevalence and incidence of CHD and other CVDs in Puerto Rican males.

PACS evaluated the types, incidence, course, and outcome of pulmonary disorders in newly diagnosed cases of AIDS, newly diagnosed cases of AIDS-related complex and newly diagnosed asymptomatic HIV infection.

RESTORE evaluated whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol would experience fewer days of mechanical ventilation than patients receiving usual care.

The ROSTERS study evaluated whether implementation of a schedule that eliminated shifts ≥24 hours for resident-physicians would result in improved patient safety.

REACT developed and evaluated the impact of a community educational intervention program on patient delay time from onset of symptoms of an acute myocardial infarction to arrival at a hospital emergency department.

RTS evaluated and compared the effectiveness of sustained-release nifedipine, and the effectiveness of temperature biofeedback, for the treatment of patients with Primary Raynaud's Phenomenon.

The REVIVAL study targeted a population of ambulatory patients with chronic, advanced systolic heart failure that have known high-risk features for increased mortality and hospitalization to provide a greater understanding of the clinical trajectory of these patients and to determine the relationship between baseline clinical measures and prognosis.

ROMICAT-II compared the effectiveness of a coronary computed tomographic angiography (CCTA) based evaluation strategy with that of standard evaluation in the emergency department in reducing hospital stay length for patients with symptoms suggestive of an acute coronary syndrome.

The SCDIC registry aimed to understand the barriers to care and other factors related to reduced healthcare utilization after the transition from pediatric to adult sickle cell disease care which may contribute to increased morbidity and mortality.

SHHS assessed the cardiovascular and other consequences of sleep-disordered breathing and tested whether sleep-disordered breathing is associated with an increased risk of CHD, stroke, all-cause mortality and hypertension.

SOLVD evaluated the effects of enalapril, an ACE inhibitor, on long-term mortality and major morbidity in a group of patients with left ventricular dysfunction. Included were a Prevention Trial of patients with low ejection fraction but no overt symptoms of congestive heart failure, a Treatment Trial of patients with low ejection fraction and symptoms of CHF, and a registry.

STAN tested whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control in children and adults.

The SNAP trial was designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2).

SPIROMICS sought to identify homogeneous subgroups of chronic obstructive pulmonary disease patients for targeted enrollment in future therapeutic clinical trials, as well as to identify and conduct preliminary validation of intermediate biological or clinical outcomes for use as clinical trial endpoints.

SCD-HEFT evaluated the hypothesis that amiodarone or a conservatively programmed shock-only, single-lead implantable cardioverter defibrillator would decrease the risk of death in patients with mild-to-moderate heart failure.

STICH compared medical therapy with coronary bypass surgery and/or surgical ventricular reconstruction for patients with congestive heart failure and coronary artery disease. STICHES extended the follow-up of surviving subjects randomized to the myocardial revascularization hypothesis.

SPRINT tested the hypothesis that treating systolic blood pressure to a goal lower than the current recommendation would reduce the incidence of CVD.

SHEP assessed the ability of antihypertensive drug treatment to reduce the risk of nonfatal and fatal stroke in isolated systolic hypertension.

TCD evaluated the impact of ex vivo T-Cell Depletion of marrow as compared with unmodified grafts on disease-free survival in recipients of unrelated donor bone marrow transplants.

JHS is an ongoing study that aims to investigate the associations of biological, psychosocial, and behavioral factors with the incidence atherosclerotic events and health outcomes in an African American cohort, and increase access to and the participation of African American populations and scientists in biomedical research and professions. Data from visit 1-3 examination cycles, annual follow-up through 2016, and events through 2014 are available.

LHMP brought the distinct efforts of six clinical centers together under a single infrastructure, creating a collaborative network. The goals of the project were to characterize the microbiome of the lung and respiratory tract, and enhance understanding of the role of the lung microbiome in preserving health or causing disease and in the divergent effects observed in HIV-infected versus uninfected individuals.

SOYA evaluated whether participants with poorly controlled asthma would have improved asthma control and lung capacity when prescribed a soy isoflavone supplement versus a placebo.

THAPCA-IH evaluated the efficacy of therapeutic hypothermia compared to therapeutic normothermia at increasing survival rates and decreasing neurologic deficits in comatose infants and children who experienced an in-hospital cardiac arrest.

THAPCA-OH evaluated the efficacy of therapeutic hypothermia compared to therapeutic normothermia at increasing survival rates and decreasing neurologic deficits in infants and children who experience an out-of-hospital cardiac arrest.

TIMI II assessed whether intravenous tissue-type plasminogen activator given in the early hours of acute myocardial infarction should be followed by percutaneous transluminal coronary angioplasty.

TIMI III investigated the role of a thrombotic agent added to conventional medical therapies and compared an early invasive management strategy to a more conservative early strategy in patients with unstable angina and non-Q wave myocardial infarction.

TSS established two donor-recipient repositories consisting of a serum repository from donors in high AIDS prevalence areas in the U.S. and a plasma and cell repository from blood donors, transfusion and other blood product recipients and control cohorts. The repository has been used to evaluate factors influencing the risk of transfusion-transmitted HIV infection and its progression to clinically significant manifestations.

The TOP study investigated the effects of higher hemoglobin threshold transfusions on neurodevelopmental impairment in extremely-low-birth-weight infants.

TTVS established a repository of specimens collected from prospectively identified cases of non-A, non-B (NANB) hepatitis after blood transfusion. The major intentions were to determine the incidence of that occurrence, identify the characteristics of the donors associated with the event and have a resource available to compare laboratory donor screening methods during the study and in subsequent years following completion of the study.

TOPCAT evaluated the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Walk-PHaSST assessed whether sildenafil is effective and safe for sickle cell disease patients who develop pulmonary hypertension. The trial was terminated early due to the unforeseen increase in adverse events in participants treated with sildenafil as compared to placebo. Therefore, the majority of subject data were collected from the screening phase of the study.

TAAG tested the effectiveness of a multicomponent school-based and community-linked intervention in preventing the decline in physical activity levels and cardiovascular fitness in middle school girls.

TOLSURF assessed whether late surfactant treatment in extremely low gestational age newborn infants requiring ventilation at 7-14 days would safely improve survival without bronchopulmonary dysplasia.

The TRIM study investigated the efficacy of roflumilast for the treatment of poorly controlled asthma in people with obesity. While roflumilast increased risk of asthma exacerbation, weight loss of at least 5% was associated with improved asthma control.

TACT aimed to separately determine if (1) ethylene diamine tetra-acetic (EDTA) chelation therapy and (2) oral multivitamins are safe and effective in reducing cardiovascular events in individuals with a history of myocardial infarction.

TRAP examined whether the use of platelets from which leukocytes had been removed by a filter or that had been treated with ultraviolet B irradiation would prevent the formation of antiplatelet alloantibodies and refractoriness to platelet transfusions.

Phase I of TOHP was designed to test the short-term feasibility and efficacy of seven non-pharmacologic interventions in persons with high-normal blood pressure. Phase II was designed to test the efficacy of interventions to promote weight loss, sodium reduction, and the combination thereof in decreasing BP and incidence of hypertension in overweight adults with a high-normal diastolic BP.

VA2-TAH was designed to test the efficacy of hepatitis B immune serum globulin for the prevention or modification of post-transfusion hepatitis as compared to immune serum globulin.

VATS compared the effects of leukocyte-reduced and unmodified red blood cell transfusions on survival, complications of acquired immunodeficiency syndrome and relevant laboratory markers in HIV-infected patients.

WRAP-IPF was a multicenter randomized clinical trial designed to determine if the reduction of abnormal gastro-esophageal reflux with laparoscopic anti-reflux surgery will slow the progression of idiopathic pulmonary fibrosis as measured by forced vital capacity.

WLM compared the long-term effects of two weight loss maintenance intervention groups, one receiving behavioral intervention through personal counseling and the other receiving behavioral intervention through web-based individually tailored interactive technology, versus a self-directed/usual care control group.

WAVE investigated the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease.

The WHI clinical trial assessed the safety and efficacy of three interventions on CVD, cancer, and osteoporosis in postmenopausal women. The interventions of interest were hormone therapy, dietary modification, and calcium/vitamin D supplementation. The WHI observational study examined the relationship between lifestyle, socioeconomic, health, and other risk factors with cardiovascular, breast cancer, colorectal cancer and osteoporotic fracture outcomes in postmenopausal women. Additional data are available from the extension studies and ancillary memory study.

WISE was designed to: 1) optimize symptom evaluation and diagnostic testing for ischemic heart disease; 2) explore mechanisms for symptoms and myocardial ischemia in the absence of epicardial coronary artery stenoses, and 3) evaluate the influence of reproductive hormones on symptoms and diagnostic test response.

The LILAC substudy was initiated to collect information on cancer treatment and long-term outcomes in women diagnosed with eight selected cancers during their participation in WHI.