Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Cardiovascular Diseases Clinical Trial

Official title:

Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010608
• Other study ID #: P50 AT000082-01P2
• Secondary ID: P50AT000082-01P5
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: December 4, 2009
• Start date: October 1999
• Est. completion date: July 2006

Study information

• Verified date: December 2009
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Transcendental Meditation
a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.
• Health Education
didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake

Locations

Country	Name	City	State
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Maharishi University of Management	Fairfield	Iowa
United States	Howard University Medical Center	Washington, Dc	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)	Howard University, Morehouse College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography		one year	No