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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., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Background: The purpose of this report is to present a model of physicians in full-time clinical practice participating as investigators in multicenter clinical trials, sponsored by a pharmaceutical or medical device company., Methods: This gas-exchange substudy was conducted as a pilot study to establish the feasibility of the 10-member EXERcise testing group of the Duke University Cooperative Cardiovascular Society (EXERDUCCS) consortium to perform a complex multicenter trial using cardiopulmonary exercise testing. An active interchange of information was established involving the principal investigator for the substudy, a dedicated full-time project coordinator, a medical director of the overall EXERDUCCS network site, the project coordinator for the sponsor, and all the participating EXERDUCCS investigators and coordinators., Results: The sponsor set as a goal of enrollment of 6 subjects per site, and 8 of the 10 sites met this goal. As a result of the successful enrollment and completion of the study and substudy by the EXERDUCCS sites, the sponsor subsequently increased the payment stipends to the sites to compensate for the extra work and expense incurred., Conclusions: This cooperative experience accomplished several goals: (1) it allowed a complex clinical trial to be successfully completed in a time frame which would not have been possible using only single unconnected sites; (2) it educated the physician-investigators (and their personnel) in exercise cardiopulmonary; and (3) it prepared the sites for future clinical trials involving this methodology.

Mitral valve prolapse is sometimes associated with chest pain, but this symptom may also be caused by coexisting coronary disease. The accuracy of exercise echocardiography in diagnosing coronary disease in these patients and the most cost-efficient diagnostic approach are unclear. We studied 96 patients (aged 59 +/- 12 years; 70 men) with mitral valve prolapse who underwent exercise electrocardiography, exercise echocardiography, and coronary angiography. The accuracies of seven diagnostic strategies based on the current and expected use of exercise electrocardiography and exercise echocardiography in patients with mitral valve prolapse were examined, with the costs calculated based on Medicare reimbursement. Thirteen (13.5%) patients had significant coronary artery disease. The sensitivity and specificity of exercise electrocardiography in the 71 patients with interpretable electrocardiograms were 50% and 72%, respectively. For the 73 patients who achieved >85% of maximal heart rate, 52 had interpretable exercise electrocardiograms (sensitivity 50%; specificity 69%). Exercise echocardiography had a sensitivity of 69% and a specificity of 98% in the 96 patients and a sensitivity of 82% and a specificity of 96% in patients who achieved >85% of maximal heart rate. Approaches adopting Bayes' theorem and restricting further investigation to patients with at least intermediate pretest probability of coronary disease were the least costly. When combined with exercise echocardiography as the initial test, clinical stratification was associated with a false-negative rate of 21%. The utility of exercise electrocardiography is limited by the high prevalence of resting electrocardiographic abnormalities and suboptimal sensitivity and specificity. The best balance of cost and diagnostic accuracy is to perform exercise echocardiography in patients with at least intermediate probability of coronary artery disease.

In the United States there has been a dramatic decrease in age-adjusted coronary heart disease (CHD) mortality during the last 20 years. This article investigates the reasons for this decline and concludes that most of the decline in CHD has been the result of life-style changes, particularly reduction in serum cholesterol and cigarette smoking. The CHD Policy Model is used to compare the effect of a targeted versus a population-wide program of cholesterol reduction. On the basis of these projections, population-wide interventions are considered an important part of cholesterol reduction programs. The article also assesses the cost-effectiveness of selected cardiac interventions, for example, screening exercise tolerance tests, coronary care units, thrombolysis in acute myocardial infarction, and beta-blockers in patients after myocardial infarction. Cost-effectiveness analysis is seen to be crucial as medical costs escalate and the population at risk from CHD increases.