Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00010608

Purpose

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	Intervention	Phase
Cardiovascular Diseases	Procedure: Meditation Behavioral: Health Education	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind
Official Title:	Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography

Estimated Enrollment:

196

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010608

Locations

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

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Robert H. Schneider, MD

Center for Health and Aging Studies

More Information

Study ID Numbers:	P50 AT000082-01P2, P50AT000082-01, P50AT000082-02
Study First Received:	February 2, 2001
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00010608
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

CVD

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009