A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans

Cardiovascular Disease Clinical Trial

— Milw  

Official title:

Stress Reduction and Cardiovascular Disease Morbidity and Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299935
• Other study ID #: R01HL048107
• Status: Completed
• Phase: Phase 2
• Start date: January 1998
• Est. completion date: July 2007

Study information

• Verified date: April 2022
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Transcendental Meditation
The Transcendental Meditation program is the principal mind-body approach of Maharishi Ayurveda, originating from the ancient Vedic tradition and introduced 50 years ago by Vedic scholar and teacher Maharishi Mahesh Yogi. The Transcendental Meditation technique is described as a simple and natural procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. Practice of the Transcendental Meditation technique does not require any changes in personal beliefs, philosophy or lifestyle. During the practice a unique state of restful alertness is gained. Acute and chronic physiological effects have been documented. The course is taught by instructors certified by Maharishi Foundation - USA.
• Health Education
health education is taught in a clinical setting using standard AHA recommendations for proper diet, exercise and control of substance usage but without a stress management component.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Maharishi International University	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke		every six months for an average of 5.4 years
Secondary	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
Secondary	psychosocial distress factors	psychometric factors included depression, hostility and anger using standardized psychometric instruments - Center for Epidemiological Depression Scale (CES-D), Cook-Medley Hostility Inventory (Ho), Anger Expression Scale (AX)	annually for an average of 5.4 years
Secondary	blood pressure	BP was assessed by standard clinical trial technique using multiple seated measurements in the research clinic	every six months for an average of 5.4 years
Secondary	behavioral and lifestyle factors	smoking, alcohol use, physical activity and dietary patterns were assessed by standard questionnaire. Body mass index was measured by balance and scale.	annually for an average of 5.4 years

External Links

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