STRESS REDUCTION AND CVD MORBIDITY AND MORTALITY IN BLACKS-II

描述(由申请人提供)：与美国白人相比，非裔美国人的心血管疾病发病率和死亡率高得不成比例。大量证据表明，高水平的心理社会和社会环境压力导致了这一人群的过度发病率和死亡率。在早期对非裔美国人和其他心血管疾病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--超验冥想(TM)计划--与显著减少心血管疾病风险因素和临床心血管疾病的替代标记物有关。这些包括高血压、心肌缺血和颈动脉粥样硬化的临床显著减少，以及心理社会压力和生活质量的改善。在之前由NHLBI赞助的临床试验中，201名患有有记录的冠心病的非裔美国人男性和女性(平均年龄59岁)被随机分为TM计划减压组和健康教育对照组。结果显示，在中位数三年的随访期后，减压组与对照组相比，合并死亡率和心血管疾病发病率降低了50%(RR=.50，p&lt；0.05)。为这项拟议的研究做准备的初步分析表明，仅发生“硬”事件--死亡率、心肌梗死和中风的风险较低(RR=.42；P=.15)。拟议的研究将对之前对201名非洲裔美国人参与者进行的干预和测试进行长期跟踪，并再资助五年。这项研究将明确评估与对照相比，行为压力减轻对“硬”心血管终点的长期影响，以及对“硬”和“软”心血管终点(全因死亡率、心肌梗死、中风、冠状动脉再血管化以及因心力衰竭和缺血性心脏病住院的非心肌梗死)的无病生存的可持续性。次要结果将包括传统的心血管疾病风险因素(血压、血脂、饮食、锻炼、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，这是唯一一项针对非裔美国人男性和女性心血管疾病二级预防的行为应激减轻的随机对照试验。这项独特的长期研究的结果将为消除卫生方面的种族和民族差异贡献重要的新知识。

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.