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

描述(由申请者提供)：广泛的挑战领域是：09健康差距。具体的挑战主题是：开发工具来检测健康差距的早期指标，并测试协作干预措施以减少心、肺和血液疾病的不同医疗保健或结果：09-HL-101。非裔美国人的心血管疾病死亡率是白人的两倍。冠心病(CHD)是造成这种健康差距的主要原因，因为与白人相比，非裔美国人男性和女性的CHD死亡率高出50%。流行病学证据表明，过度的心理社会和社会环境压力导致了这些不成比例的冠心病死亡率和发病率。尽管有这些公共卫生模式，但之前还没有临床试验来评估在高危非裔美国人的冠心病标准二级预防计划中添加减压训练的有效性。先前的对照临床研究表明，先验冥想(TM)计划的压力减轻与非裔美国人男性和女性的CHD风险因素、替代CHD终点和临床心血管事件的减少有关。这些有益的变化包括高血压、心理社会压力、胰岛素抵抗-代谢综合征、心肌缺血、颈动脉粥样硬化、左心室肥厚和死亡率的减少。正电子发射断层扫描(PET)是一种高度敏感和特异的无创性工具，用于量化冠状动脉疾病的变化。一项在非裔美国人冠心病患者中使用心脏PET的初步研究表明，在II期试验中使用这项技术来确定冠心病患者的减压效果是可行的。因此，本研究的总体目标是进行一项随机对照试验，以确定在非裔美国人的冠心病二级预防中，使用和不使用结构化、标准化和有效的应激减轻成分的心脏康复的有效性。在这项第二阶段试验中，56名患有冠心病的非裔美国人男性和女性将被随机分配到标准心脏康复组和标准心脏康复组，其中一组使用先验冥想计划进行正式的压力减轻训练，另一组只接受标准心脏康复。干预期为12周。在基线和后测时，受试者将接受定量正电子发射计算机断层扫描(PET)检测心肌灌注和缺血情况。次要结果包括CHD的生理、行为和心理社会危险因素。干预计划的参与者资格标准和方案要素与联邦医疗保险第二阶段心脏康复/二级预防指南一致。现场将是哥伦比亚大学医学中心，协调中心将是MUMRI-自然医学和预防中心。这项研究将是第一次直接评估减压训练对患有有记录的心脏病的非裔美国人男性和女性的冠心病二级预防的贡献。与大多数人相比，非裔美国人死于心血管疾病的比率高出两倍。大量证据表明，过高的社会心理压力和环境压力是造成这种公共健康差距的原因。这将是第一次临床试验，评估与单独使用标准心脏护理相比，减压和标准心脏护理在改善患有已知冠心病的非裔美国人男性和女性的心脏病过程中的有用性。

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.