Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.

Detailed Description
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Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population. Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.

Official Title
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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Transcendental Meditation
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American, self-identified Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis Informed consent Written Permission of participant's referring physician

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcendental Meditation program<br>A mental technique for stress reduction which is natural, easy and effortless and is practiced sitting in a chair with eyes closed for 20 minutes twice a day. | Behavioral: Transcendental Meditation<br>* a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.<br>|
| Active Comparator: Health Education<br>A lifestyle modification program for improving diet, exercise, salt intake and substance use. | Behavioral: Health Education<br>* didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVD