RCT of Stress Reduction in the Secondary Prevention of CHD in African Americans

Institute For Prevention Research, Maharishi Vedic City IA

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Abstract

DESCRIPTION (provided by applicant): The broad Challenge Area is: 09 Health Disparities. The specific Challenge Topic is: Develop tools to detect early indicators of health disparities, and to test collaborative interventions to reduce differential health care or outcomes for heart, lung, and blood diseases: 09-HL-101. The mortality rate from cardiovascular disease is twice as high in African Americans as white Americans. Coronary heart disease (CHD) is a major cause of this health disparity since mortality rates from CHD are 50 percent greater in African American men and women compared to whites. Epidemiological evidence implicates excessive psychosocial and socio-environmental stress in these disproportionate rates of CHD mortality and morbidity. Despite these public health patterns, there have been no previous clinical trials to assess the efficacy of stress reduction training added to standard secondary prevention programs for CHD in high risk African Americans. Previous controlled clinical studies have demonstrated that stress reduction with the Transcendental Meditation (TM) program is associated with reductions in CHD risk factors, surrogate CHD endpoints and clinical cardiovascular events in African American men and women. These beneficial changes include reductions in hypertension, psychosocial stress, insulin resistance-metabolic syndrome, myocardial ischemia, carotid atherosclerosis, left ventricular hypertrophy, and mortality rates. Positron emission tomography (PET) is a highly sensitive and specific noninvasive tool for quantifying changes in coronary artery disease. A preliminary study using cardiac PET in African American subjects with CHD demonstrated the feasibility of using this technology in a phase II trial to determine the efficacy of stress reduction in patients with CHD. Therefore, the overall objective of the present study is to conduct a randomized controlled trial to determine the efficacy of cardiac rehabilitation with and without a structured, standardized, and validated stress reduction component in the secondary prevention of CHD in African Americans. In this phase II trial, 56 African American men and women with established CHD will be randomly allocated either to standard cardiac rehabilitation with formal stress reduction training using the Transcendental Meditation program or to standard cardiac rehabilitation alone. The intervention period will be 12 weeks. At baseline and posttest, subjects will be tested by quantitative PET for myocardial perfusion and ischemia. Secondary outcomes comprise physiological, behavioral and psychosocial risk factors for CHD. Participant eligibility criteria and programmatic elements of the intervention programs are consistent with Medicare guidelines for phase II cardiac rehabilitation/secondary prevention. The field site will be Columbia University Medical Center and the coordinating center will be MUMRI-Center for Natural Medicine and Prevention. This study will be the first of its kind to directly evaluate the contributions of stress reduction training to the secondary prevention of CHD in African American men and women with documented heart disease. African Americans suffer from two-fold higher rates of mortality from cardiovascular disease compared to the majority population. Substantial evidence indicates that disproportionately high levels of psychosocial and environmental stress contribute to this public health disparity. This will be the first clinical trial to evaluate the usefulness of stress reduction combined with standard cardiac care compared to standard cardiac care alone in modifying the heart disease process in African American men and women with known coronary heart disease.