Clinical trial NCT01299935: A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans
Official title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Heart Disease
Cardiovascular Disease
Keywords: stress reduction
Transcendental Meditation technique
secondary prevention of coronary heart disease
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2011-02-21
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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Primary outcomes:
measure: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke
timeFrame: every six months for an average of 5.4 years
Secondary outcomes:
measure: composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for heart failure, unstable angina or ischemic heart disease - non-MI.
timeFrame: every six months for average of 5.4 years
measure: psychosocial distress factors
timeFrame: annually for an average of 5.4 years
measure: blood pressure
timeFrame: every six months for an average of 5.4 years
measure: behavioral and lifestyle factors
timeFrame: annually for an average of 5.4 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Maharishi International University
name: Robert H Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider RH, Grim CE, Rainforth MV, Kotchen T, Nidich SI, Gaylord-King C, Salerno JW, Kotchen JM, Alexander CN. Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):750-8. doi: 10.1161/CIRCOUTCOMES.112.967406. Epub 2012 Nov 13.