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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
This study has been completed.
Study NCT00010608   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: February 2, 2001   Last Updated: August 17, 2006   History of Changes

February 2, 2001
August 17, 2006
 
 
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Same as current
Complete list of historical versions of study NCT00010608 on ClinicalTrials.gov Archive Site
 
 
 
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind
Cardiovascular Diseases
  • Procedure: Meditation
  • Behavioral: Health Education
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
196
 
 

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
Female
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010608
 
P50 AT000082-01P2, P50AT000082-01, P50AT000082-02
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Robert H. Schneider, MD Center for Health and Aging Studies
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP