Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Enrollment
- 196
- Locations
- 3
- Primary Endpoint
- Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Time Frame: one year