STRESS REDUCTION & CVD MORBIDITY & MORTALITY IN BLACKS

描述（改编自申请人摘要）：心血管疾病 (CVD)非洲的死亡率和发病率明显高于 美国人比白人多。 黑人高血压的发病率较高， 这一差异的主要贡献者。 许多研究表明， 心理社会应激在非洲高血压和心血管疾病病因中的作用 美国人 研究人员在短期试验和 长期随机临床试验，轻度高血压和 心理社会压力可以显着减少在内城非洲 美国人通过超越冥想（TM）减轻压力 与身体放松或教育控制相比。 荟萃分析显示，类似的血压下降幅度为20%至40 几年来CVD事件减少。 的初步数据 非洲城市高血压患者减压研究 美国人表示，经过五年的随访，TM组有64 与对照组相比，CVD死亡率和发病率风险降低百分比 (by意向治疗分析）。 所有原因的死亡率都类似地下降。 另一项初步试验表明，在所有原因和心血管疾病， 老年白人受试者15年随访期间的死亡率 练习这种减压方法。 目前的建议将延长 本研究通过调查减压（TM）的有效性 计划）在预防高风险非洲人的心血管疾病发病率和死亡率方面的作用 美国人 这将是一项为期5年的随机、单盲、对照， 在374名患有轻度高血压、LVH、 还有CHD 这些临床因素的结合已经显示，在最近的 流行病学研究将非洲心血管疾病死亡率的风险增加两倍 美国人 男性和女性受试者将在医学中心招募 位于密尔沃基的威斯康星州学院医院是全国最大的医院 非裔美国人CHD患者登记处。 基线后，受试者将 随机分为TM组或健康教育对照组， 常规医疗护理。 通过生存期评价的主要结局 分析将结合CVD死亡率和发病率事件（包括 心肌梗死、卒中、冠状动脉血运重建和CVD 住院）。心血管疾病的危险因素-包括血压，血脂，吸烟，运动， 心理社会压力、生活质量和依从性-将进行评估 沿着半年一次，主要临床结局超过平均值 四年随访。 还将进行方案评估， 评估成本效益和治疗交付和临床培训 因素 如果成功，这项研究将证明疗效， 行为减压法预防心血管病的可行性研究 发病率和死亡率，并改善生活质量，在这个高风险， 服务不足的少数民族。

DESCRIPTION (Adapted from the applicant's abstract): Cardiovascular disease (CVD) mortality and morbidity rates are significantly higher in African Americans than in whites. Greater rates of hypertension in blacks are a major contributor to this differential. Numerous studies implicate chronic psychosocial stress in the etiology of hypertension and CVD in African Americans. The investigators have shown in both a short-term trial and in a longer-term randomized clinical trial, that mild hypertension and psychosocial stress can be significantly reduced in inner-city African Americans through stress reduction with the Transcendental Meditation (TM) program compared to physical relaxation or education controls. Meta-analyses have associated similar BP reductions with 20 to 40 percent less CVD events over several years. Preliminary data from the investigators' trial of stress reduction with hypertensive urban African Americans indicated that after a five-year follow-up, the TM group had a 64 percent reduction in CVD mortality and morbidity risk compared to controls (by intent-to-treat analysis). All cause mortality decrease similarly. Another preliminary trial indicated a similar decreased in all-cause and CVD mortality over 15 years of follow-up in elderly Caucasian subjects practicing this stress reduction approach. The current proposal will extend this research by investigating the effectiveness of stress reduction (TM program) in preventing CVD morbidity and mortality in high risk African Americans. This will be a five-year, randomized, single-blind, controlled, community-based trial of 374 African Americans with mild hypertension, LVH, and CHD. The combination of these clinical factors has been shown in recent epidemiological studies to triple the risk for CVD mortality in African Americans. Male and female subjects will be recruited at the Medical College of Wisconsin Hospitals in Milwaukee from the country s largest registry of African Americans with CHD. After baseline, subjects will be randomized to either TM or a health education control while continuing their usual medical care. The primary outcomes to be evaluated by survival analysis will be combined in CVD mortality and morbidity events (including myocardial infarction, stroke, coronary revascularization and CVD hospitalization ). CVD risk factors-including BP, lipids, smoking, exercise, psychosocial stress, quality of life, and compliance-will be evaluated semi-annually along with the primary clinical outcomes over an average four-year follow-up. A program evaluation will also be conducted to evaluate cost effectiveness and treatment delivery and clinical training factors. If successful, this study will demonstrate the efficacy and feasibility of a behavioral stress reduction method in preventing CVD morbidity and mortality and improving quality of life in this high risk, underserved minority population.