Stress Reduction and Cardiovascular Disease Morbidity and Mortality
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Maharishi International University
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Robert Schneider, MD
Director, Center for Natural Medicine and Prevention
Maharishi International University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke
Time Frame: every six months for an average of 5.4 years
Secondary Outcomes
- 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)