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

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Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

This study has been completed.

Study NCT00010608. Last updated on August 17, 2006. Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Official Title ^†

Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

Condition ^†

Cardiovascular Diseases

Intervention ^†

Procedure: Meditation
Behavioral: Health Education

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

196

Start Date ^†

Completion Date

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

Gender

Female

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00010608

Organization ID

P50 AT000082-01P2

Secondary IDs ^††

P50AT000082-01, P50AT000082-02

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Robert H. Schneider, MD

Center for Health and Aging Studies

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2006

First Received Date ^†

February 2, 2001

Last Updated Date

August 17, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.