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

非裔美国人冠心病二级预防中减压的随机对照试验

• 批准号: 7937723
• 负责人: ROBERT SCHNEIDER
• 金额: $ 49.96万
• 依托单位: INSTITUTE FOR PREVENTION RESEARCH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937723
• 关键词: Academic Medical Centers; African American; Alcohol consumption; Ammonia; Area; Behavioral; Blood Pressure; Blood flow; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; Carotid Atherosclerotic Disease; Chronic; Clinical; Clinical Research; Clinical Trials; Coronary; Coronary Arteriosclerosis; Coronary heart disease; Data; Decision Making; Disease; Distress; Elements; Eligibility Determination; Epidemiology; Ethnic Origin; Event; Feasibility Studies; Future; Guidelines; Health Policy; Healthcare; Heart; Heart Diseases; Hematological Disease; Hypertension; Image; Individual; Insulin Resistance; Intervention; Ischemia; Left Ventricular Hypertrophy; Lipids; Lung; Measures; Medicare; Medicine; Mental Depression; Metabolic syndrome; Methods; Modeling; Morbidity - disease rate; Myocardial; Myocardial Ischemia; Myocardial perfusion; New York City; Outcome; Participant; Patients; Pattern; Phase; Phase II Clinical Trials; Physiological; Policies; Population; Positron-Emission Tomography; Prevention; Prevention program; Process; Psychosocial Factor; Psychosocial Stress; Public Health; Race; Randomized Controlled Trials; Regression Analysis; Rehabilitation therapy; Rest; Risk; Risk Factors; Secondary Prevention; Serum; Site; Smoke; Social isolation; Stress; Structure; Technology; Testing; Training; Transcendental Meditation; Woman; biobehavior; caucasian American; diet and exercise; evidence base; health disparity; heart disease risk; high risk; intervention program; men; mortality; primary outcome; programs; psychosocial; racial and ethnic; secondary outcome; standardize measure; tool; trend

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.

描述（由申请人提供）：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，以发现健康差异的早期指标，并测试协作干预措施，以减少心脏、肺和血液疾病的差异卫生保健或结果：09-HL-101。非裔美国人心血管疾病的死亡率是美国白人的两倍。冠心病（CHD）是造成这种健康差异的主要原因，因为非裔美国男性和女性的冠心病死亡率比白人高50%。流行病学证据表明，过度的社会心理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。尽管有这些公共健康模式，但之前还没有临床试验来评估将减压训练加入到标准的冠心病二级预防项目中对高危非裔美国人的疗效。先前的对照临床研究表明，在非裔美国男性和女性中，超觉冥想（TM）项目的压力减轻与冠心病风险因素、替代冠心病终点和临床心血管事件的降低有关。这些有益的改变包括高血压、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降低。正电子发射断层扫描（PET）是一种高度敏感和特异性的非侵入性工具，用于量化冠状动脉疾病的变化。一项在非裔美国冠心病患者中使用心脏PET的初步研究证明了在II期试验中使用这项技术来确定冠心病患者减压效果的可行性。因此，本研究的总体目标是进行一项随机对照试验，以确定有无结构化、标准化和经过验证的减压成分的心脏康复在非裔美国人冠心病二级预防中的疗效。在这项II期试验中，56名患有冠心病的非裔美国男性和女性将被随机分配，要么接受标准的心脏康复训练，包括使用超觉冥想项目进行正式的减压训练，要么接受标准的心脏康复训练。干预期为12周。在基线和测试后，受试者将通过定量PET检测心肌灌注和缺血。次要结局包括冠心病的生理、行为和社会心理风险因素。受试者资格标准和干预方案的规划要素符合医疗保险II期心脏康复/二级预防指南。实地地点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。这项研究将是同类研究中首次直接评估减压训练对非裔美国男性和女性冠心病二级预防的贡献。非裔美国人患心血管疾病的死亡率是大多数人的两倍。大量证据表明，过高的社会心理和环境压力造成了这种公共卫生差距。这将是第一个评估减压结合标准心脏护理的有效性的临床试验，与单独的标准心脏护理相比，在改变患有冠心病的非裔美国男性和女性的心脏病过程中。