STRESS REDUCTION AND CVD MORBIDITY AND MORTALITY IN BLACKS-II

描述（由申请人提供）：与白色美国人相比，非裔美国人的心血管疾病发病率和死亡率不成比例地高。大量证据表明，社会心理和社会环境压力大是造成这一人群发病率和死亡率过高的原因。在早期对非裔美国人和其他CVD高危人群进行的对照试验中，目前的合作团队证明，一种选定的减压方法，即超越冥想（TM）计划，与CVD风险因素和临床CVD替代标志物的显着减少有关。这些包括高血压、心肌缺血和颈动脉粥样硬化的临床显著降低，以及心理社会压力和生活质量的改善。在之前NHLBI赞助的临床试验中，201名患有冠心病的非洲裔美国男性和女性（平均年龄59岁）被随机分配到TM计划或健康教育对照组。结果显示，在中位三年随访期后，减压组的死亡率和心血管疾病发病率比对照组低50%（RR = 0.50，p <0.05）。为准备拟议的研究而进行的初步分析表明，单独的“硬”事件风险较低-死亡率，MI和中风（RR= 0.42; p = 0.15）。 这项拟议的研究将对201名非洲裔美国人参与者的先前试验进行长期随访和测试，为期五年。本研究将明确评估与对照组相比，行为应激减轻对“硬”CVD终点的长期影响，以及对“硬”和“软”CVD终点（全因死亡率、MI、卒中、冠状动脉血运重建和因心力衰竭和缺血性心脏病住院，非MI）的无病生存期的可持续性。次要结局将包括传统的CVD风险因素（BP，血脂，饮食，运动，体重），心理社会风险因素（抑郁，敌意，愤怒），生活质量，药物使用，依从性和成本效益。据我们所知，这是唯一的随机对照试验的行为减轻压力的二级预防心血管疾病的非洲裔美国人的男性和女性。这项独特的长期研究的结果将为消除健康方面的种族和民族差异提供重要的新知识。

DESCRIPTION (provided by applicant): African Americans suffer from disproportionately high rates of cardiovascular disease morbidity and mortality compared to white Americans. Substantial evidence indicates that high levels of psychosocial and socioenvironmental stress contribute to the excessive morbidity and mortality in this population. In earlier controlled trials with African Americans and other populations at high risk for CVD, the current collaborative team demonstrated that a selected stress reduction approach, the Transcendental Meditation (TM) program, was associated with significant reductions in CVD risk factors and surrogate markers for clinical CVD. These include clinically significant decreases in hypertension, myocardial ischemia and carotid atherosclerosis, as well as improvements in psychosocial stress and quality of life. In the previous NHLBI-sponsored clinical trial, 201 African American men and women with documented coronary heart disease (mean age 59 years) were randomized to either stress reduction with the TM program or a health education control. The results showed 50 percent lower risk of combined mortality and CVD morbidity in the stress reduction group compared to control (RR = .50, p <.05) after a median three year follow-up period. Preliminary analysis, in preparation for the proposed study, suggests lower risk of "hard" events alone--mortality, MI and stroke (RR= .42; p = .15). The proposed study will conduct long-term follow-up of intervention and testing of the previous trial of 201 African American participants for an additional five funded years. This study will definitively evaluate long-term effects of behavioral stress reduction compared to control on "hard" CVD endpoints and sustainability of disease-free survival on combined "hard" and "soft" CVD endpoints (all-cause mortality, MI, stroke, coronary revascularizations, and hospitalizations for heart failure and ischemic heart disease, non-MI). Secondary outcomes will include traditional CVD risk factors (BP, lipids, diet, exercise, weight), psychosocial risk factors (depression, hostility, anger), quality of life, medication use, compliance, and cost effectiveness. To our knowledge, this is the only randomized controlled trial of behavioral stress reduction for the secondary prevention of CVD in African American men and women. The results of this unique long-term study will contribute critical new knowledge for the elimination of racial and ethnic diparities in health.