PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.
Pamela S Douglas, Udo Hoffmann, Kerry L Lee, Daniel B Mark, Hussein R Al-Khalidi, Kevin Anstrom, Rowena J Dolor, Andrzej Kosinski, Mitchell W Krucoff, Daniel W Mudrick, Manesh R Patel, Michael H Picard, James E Udelson, Eric J Velazquez, Lawton Cooper, PROMISE investigators
Author Information
Pamela S Douglas: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH. Electronic address: pamela.douglas@duke.edu.
Udo Hoffmann: Massachusetts General Hospital, Harvard Medical School, Columbus, OH.
Kerry L Lee: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Daniel B Mark: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Hussein R Al-Khalidi: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Kevin Anstrom: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Rowena J Dolor: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Andrzej Kosinski: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Mitchell W Krucoff: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Daniel W Mudrick: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH; McConnell Heart Health Center, Columbus, OH.
Manesh R Patel: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Michael H Picard: Massachusetts General Hospital, Harvard Medical School, Columbus, OH.
James E Udelson: Tufts Medical Center, Tufts University School of Medicine, Boston, MA.
Eric J Velazquez: Duke Clinical Research Institute, Duke University School of Medicine, Columbus, OH.
Lawton Cooper: National Heart, Lung, and Blood Institute, Bethesda, MD.
BACKGROUND: Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. METHODS: The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. RESULTS: More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. CONCLUSION: Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed.
