Biologic Specimen and Data Repository Information Coordinating Center

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.