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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women



Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

For Condition: Cardiovascular Diseases
Status: No longer recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , National Heart, Lung, and Blood Institute (NHLBI),National Institute on Aging (NIA)
Synopsis: The purpose of this study is to evualuate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Single Blind
Minimum Age/Maximum Age: 60 Years/
Genders: Female
Protocol Entry 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
Total Enrollment: 196

Location and Contact Information:

Overall Study Official:
RobertSchneider,  Principal Investigator,  Center for Health and Aging Studies

Howard University Medical Center
Washington D.C.,  District of Columbia, 
United States
 

Morehouse School of Medicine
Atlanta,  Georgia, 
United States
 

Maharishi University of Management
Fairfield,  Iowa,  52557
United States
 


Additional Information:
Study ID Numbers:
  1 P50 AT00082-01P2;  1-P50AT00082-01,5-P50AT00082-02
Study Start Date: 
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010608

Other Cardiovascular Diseases Studies:
1. Modifying Oxidative Damage in WAVE - Ancillary to WAVE

2. Women's Health Initiative (WHI)

3. Jackson Heart Study (JHS)

4. Multicenter Investigation of Limitation of Infarct Size (MILIS)

5. Anticoagulation, Vitamins, and Endothelial Function

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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

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