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.

Condition	Treatment or Intervention	Phase
Cardiovascular Diseases	Procedure: Meditation  Behavior: Health Education	Phase II

Further Study Details: 

Expected Total Enrollment:  196

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.

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Female

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

District of Columbia
      Howard University Medical Center, Washington, DC,  District of Columbia,  United States
Georgia
      Morehouse School of Medicine, Atlanta,  Georgia,  United States
Iowa
      Maharishi University of Management, Fairfield,  Iowa,  52557,  United States

Study chairs or principal investigators

Robert H. Schneider, MD,  Principal Investigator,  Center for Health and Aging Studies   

Study ID Numbers:  1 P50 AT00082-01P2; 1-P50AT00082-01; 5-P50AT00082-02
Record last reviewed:  November 2004
Last Updated:  November 12, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010608
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08