Millions of Americans develop chest pain suggestive of coronary heart disease each year and often require non-invasive diagnostic testing. However, currently available tests are imprecise, robust evidence regarding optimal test choice is limited, and testing costs are rising disproportionately. Further, the role of new technology such as coronary computed tomographic angiography (CTA) is uncertain. In response, the "PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)" Trial will test the hypothesis that an initial 'anatomic'testing strategy (using CTA) is clinically superior to usual care or an initial 'functional'stress testing strategy (using physician-selected stress imaging (echocardiography or nuclear) or exercise electrocardiography)) in low-intermediate coronary artery risk patients with chest pain, and will reduce the composite primary endpoint of death, myocardial infarction, major peri-procedural complications and hospitalization for unstable angina. This 150 site pragmatic trial will randomize 10,000 symptomatic patients with clinically determined, low-intermediate risk for CAD over 24 months. All subsequent diagnostic and therapeutic management will be based on the latest clinical practice guideline recommendations and will be at the discretion of the treating care team. Patients will be followed for up to 48 months (median 2.5 years). The trial design is carefully constructed to ensure the broadest possible applicability of results by incorporating the full spectrum of practice settings, caregiver specialties, and types of tests which are immediately relevant to the clinical decisions needed to care for the vast majority of chest pain patients nationwide. Projecting a 9% event rate in the functional testing or usual care arm, enrollment of 5,000 patients in each testing arm will provide 90% power for detecting a 20% relative reduction in the composite primary endpoint. Secondary endpoints include components of the primary endpoint as well as 1) medical costs, resource utilization, cost effectiveness;2) health related quality of life. This proposal includes the lead Clinical Coordinating Center (CCC;Pamela S Douglas, PI), a Statistical and Data Coordinating Center (SDCC;Kerry L Lee, PI), an Economics and Quality of Life (EQOL;Daniel B Mark, PI), and a Diagnostic Test Core (Dx Core;Udo Hoffmann, PI). This experienced multi-speciality team will deliver the integrated services vital to PROMISE trial, including faculty and operational leadership, imaging and testing expertise, site management, patient follow up, statistical analysis and data management. Although costs of care are extremely important, only demonstration of clinical superiority in real-world settings will change practice or justify use and reimbursement of a new technology such as CTA. PROMISE, as the first large randomized comparison of two diagnostic testing strategies for patients with suspected CAD, will provide the critical evidence regarding clinical outcomes and costs of alternative approaches necessary to shape clinical practice recommendations and health care policy in patients with chest pain for years to come.
Project narrative The PROMISE ("PROspective Multicenter Imaging Study for Evaluation of Chest Pain) Trial is a 10,000 patient multicenter, randomized trial which will identify the best diagnostic approach for people with chest pain and suspected heart disease. It will determine whether coronary computed tomographic angiography (CTA) is superior to usual cardiac stress testing in improving subsequent health outcomes and reducing medical costs for up to 4 years. By determining the impact of diagnostic testing on patient health, PROMISE's results will define care and shape health policy for the millions of symptomatic people referred for stress testing each year, determine the value of stunning new technologic advances such as CTA, and address rising health care costs.
|Hemal, Kshipra; Pagidipati, Neha J; Coles, Adrian et al. (2016) Sex Differences in Demographics, Risk Factors, Presentation, and Noninvasive Testing in Stable Outpatients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial. JACC Cardiovasc Imaging 9:337-46|
|Ladapo, Joseph A; Hoffmann, Udo; Lee, Kerry L et al. (2016) Changes in Medical Therapy and Lifestyle After Anatomical or Functional Testing for Coronary Artery Disease. J Am Heart Assoc 5:|
|Pagidipati, Neha J; Hemal, Kshipra; Coles, Adrian et al. (2016) Sex Differences in Functional and CTÂ Angiography Testing in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol 67:2607-16|
|Mark, Daniel B; Anstrom, Kevin J; Sheng, Shubin et al. (2016) Quality-of-Life Outcomes With Anatomic Versus Functional Diagnostic Testing Strategies in Symptomatic Patients With Suspected Coronary Artery Disease: Results From the PROMISE Randomized Trial. Circulation 133:1995-2007|
|Shah, Rohan; Yow, Eric; Jones, William Schuyler et al. (2016) Comparison of visual assessment of coronary stenosis with independent quantitative coronary angiography: Findings from the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial. Am Heart J 184:1-9|
|Mark, Daniel B; Federspiel, Jerome J; Cowper, Patricia A et al. (2016) Economic Outcomes With Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease. Ann Intern Med 165:94-102|
|Fordyce, Christopher B; Newby, David E; Douglas, Pamela S (2016) Diagnostic Strategies for the Evaluation of Chest Pain: Clinical Implications From SCOT-HEART and PROMISE. J Am Coll Cardiol 67:843-52|
|Douglas, Pamela S (2016) Achieving the Full "PROMISE" of Imaging Outcomes Research. Circulation 134:359-61|
|Douglas, Pamela S; Hoffmann, Udo; Patel, Manesh R et al. (2015) Outcomes of anatomical versus functional testing for coronary artery disease. N Engl J Med 372:1291-300|
|Trattner, Sigal; Cheng, Bin; Pieniazek, Radoslaw L et al. (2014) Sample size requirements for estimating effective dose from computed tomography using solid-state metal-oxide-semiconductor field-effect transistor dosimetry. Med Phys 41:042102|
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