Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)
Open BioLINCC Study See bottom of this webpage for request information
July 2010 – October 2014
December 22, 2017
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To compare health outcomes in patients presenting with new symptoms suggestive of coronary artery disease (CAD) that were evaluated using anatomical testing via coronary computed tomographic angiography (CTA), as compared to functional testing.
In ambulatory patients without diagnosed heart disease, new chest pain often results in noninvasive stress testing for evaluation of possible CAD. In addition to functional stress tests, CTA is another noninvasive test that has significantly higher accuracy and the ability to detect nonobstructive CAD. Therefore CTA has the potential to reduce unnecessary invasive testing and improve outcomes. However, at the time of this study, there were limited data regarding health related outcomes of the various noninvasive tests in order to identify which would be preferred in patient care, particularly for populations at very low risk. Therefore PROMISE sought to evaluate the effectiveness of noninvasive anatomical testing versus functional testing on subsequent care management and clinical outcomes.
Study participants were symptomatic outpatients requiring nonurgent and noninvasive testing for evaluation of suspected CAD. Women were required to be at least 65 years of age, or 50 to 64 years of age if they had at least one cardiac risk factor. Men were required to be at least 55 years of age, or 45 to 54 years of age if they had at least one cardiac risk factor. Risk factors were defined as diabetes, peripheral arterial disease, cerebrovascular disease, current or past tobacco use, hypertension, or dyslipidemia. Exclusion criteria were an unstable hemodynamic status or arrhythmias that required urgent evaluation for suspected acute coronary syndrome, a history of CAD or evaluation for CAD within the previous 12 months, or clinically significant congenital, valvular, or cardiomyopathic heart disease. 4,996 participants were enrolled in the CTA initial testing strategy and 5,007 participants were enrolled in the functional testing strategy.
Participants were randomly assigned to either the CTA group or the functional testing group, with stratification according to study site. Prior to randomization, the managing caregiver, site investigator, or other authorized personnel were able to choose the intended functional test if the patient were to be assigned to that study group. Functional testing included exercise electrocardiography, exercise or pharmacologic nuclear stress testing, and stress echocardiography. Contrast-enhanced CTA was performed with the use of a 64-slice or greater multidetector CT scanner. Tests were performed and interpreted by local physicians who made all subsequent clinical decisions and were encouraged to follow appropriate medical therapy. Participants received a follow-up visit at the study site at 60 days, and were contacted by telephone or mail every six months for at least one year.
The primary end point was a composite of death, myocardial infarction, hospitalization for unstable angina, or major procedural complication. Secondary end points included invasive cardiac catheterization that did not show obstructive CAD and radiation exposure.
In symptomatic patients with suspected CAD who required noninvasive testing, a strategy of initial CTA, as compared with functional testing, did not improve clinical outcomes over a median follow-up of two years.
Douglas PS, Hoffmann U, Patel MR, et al. Outcomes of Anatomical versus Functional Testing for Coronary Artery Disease. The New England journal of medicine. 2015;372(14):1291-1300. doi:10.1056/NEJMoa1415516.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 785.2 KB)
- Annotated Forms (PDF - 873.2 KB)
- Overview (PDF - 239.4 KB)
- Protocol (PDF - 729.2 KB)
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