PROspective Multicenter Imaging Study for Evaluation of chest pain: Rationale and design of the PROMISE trial
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Author
Douglas, Pamela S.
Lee, Kerry L.
Mark, Daniel B.
Al-Khalidi, Hussein R.
Anstrom, Kevin
Dolor, Rowena J.
Kosinski, Andrzej
Krucoff, Mitchell W.
Mudrick, Daniel W.
Patel, Manesh R.
Udelson, James E.
Velazquez, Eric J.
Cooper, Lawton
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https://doi.org/10.1016/j.ahj.2014.03.003Metadata
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Douglas, Pamela S., Udo Hoffmann, Kerry L. Lee, Daniel B. Mark, Hussein R. Al-Khalidi, Kevin Anstrom, Rowena J. Dolor, et al. 2014. “PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial.” American Heart Journal 167 (6) (June): 796–803.e1. doi:10.1016/j.ahj.2014.03.003.Abstract
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 two 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) anatomic 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 lab quality and completeness assessment. All subjects are followed 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: Over 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: Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed.Other Sources
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4044617/Terms of Use
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