Stress Reduction and Cardiovascular Disease Morbidity and Mortality
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke
研究概览
简要总结
This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.
详细描述
The overall objective of this randomized controlled trial is to conduct a long-term evaluation of the effects of the Transcendental Meditation (TM) program compared to health education (HE) on secondary prevention of clinical events in African American men and women with coronary artery disease (CAD). Patients (N=201; mean age 59 yrs) were enrolled with documented CAD (i.e., coronary angiogram showing at least one artery with > 50% stenosis). Patients were pretested at baseline and every 6-12 months for the duration of the study for incidence of clinical events, BP, BMI, medication usage, lifestyle behaviors, psychosocial stress factors and intervention compliance. Subjects were followed for a maximum of 9.2 years (mean 5.4 years). The investigators hypothesize that a selected stress reduction intervention, the TM program compared with a health education control may significantly reduce risk for death, myocardial infarction (MI) and stroke in African American men and women with CHD. If successful, the Transcendental Meditation program may be clinically useful in the secondary prevention of cardiovascular disease in a high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American men and women with documented coronary heart disease defined a coronary angiogram demonstrating the presence of one more coronary arteries with > or = 50% stenosis.
排除标准
- •acute MI, stroke or coronary revascularization within the previous three months; symptomatic heart failure with EF < 20%; dementia or other cognitive impairment determined clinically; and non-cardiac life threatening illness.
结局指标
主要结局
composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke
时间窗: every six months for an average of 5.4 years
次要结局
- composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for heart failure, unstable angina or ischemic heart disease - non-MI.(every six months for average of 5.4 years)
- psychosocial distress factors(annually for an average of 5.4 years)
- behavioral and lifestyle factors(annually for an average of 5.4 years)
- blood pressure(every six months for an average of 5.4 years)
研究者
Robert Schneider, MD
Director, Center for Natural Medicine and Prevention
Maharishi International University