A Randomized Controlled Trial of Meditation and Health Education on Carotid Intima-Media Thickness and Major Adverse Cardiovascular Events in Black Women and Men
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Maharishi International University
- Enrollment
- 197
- Primary Endpoint
- Carotid Intima Medial Thickness (CIMT)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation program on carotid intima-media thickness and major adverse cardiovascular events in 197 African American men and women at risk for atherosclerotic CVD. After baseline testing, participants were randomly assigned to either a stress reduction program (Transcendental Meditation) or a standard health education program. Follow up was conducted over one year and 12 years.
Detailed Description
This was a randomized, single-blind, controlled, community-based trial comparing the clinical efficacy of the Transcendental Meditation (TM) program carotid intima-media thickness and major adverse cardiovascular events (MACE) in 197 African American men and women at high risk for ASCVD. This trial compared the efficacy of the TM program to health education over one year on cIMT. Eligible participants were randomly allocated to either the TM program or health education (HE). The primary outcome was carotid intima-media thickness (IMT) assessed by B-mode ultrasonography at baseline and 12 months. Secondary outcomes were blood pressure, lipids, lifestyle, psychosocial stress and MACE. Fatal and nonfatal clinical events were assessed over one year, and mortality after 12 years.
Investigators
Robert Schneider, MD
Director and Professor, Institute for Natural Medicine and Prevention
Maharishi International University
Eligibility Criteria
Inclusion Criteria
- •race/ethnicity: African American, self-identified, age: no upper limit, gender: male or female, minimum carotid artery intima medial thickness (IMT) of at least .72 mm for men and .65 mm for women or long-term history of diabetes, myocardial infarction, coronary artery revascularization or coronary angiography indicating at least one vessel with 50% stenosis.
Exclusion Criteria
- •myocardial infarction, unstable angina, CABG, percutaneous transluminal coronary angioplasty (PTCA), or stroke within the previous three months, carotid artery endarterectomy, arrhythmia - atrial fibrillation, second or third degree AV block, congestive heart failure - class III or IV or ejection fraction less than 30 %, clinically significant valvular heart disease, clinically significant hepatic or renal failure, major psychiatric disorders, current alcohol or other drug abuse dependency disorder, non-cardiac life-threatening illness, and participating in a formal stress management program
Outcomes
Primary Outcomes
Carotid Intima Medial Thickness (CIMT)
Time Frame: 12 months
This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography
Secondary Outcomes
- major adverse cardiovascular events (MACE) - fatal(12 years)
- blood pressure(baseline, 3 and 12 months)
- lipid profile(baseline and 12 months)
- lifestyle factors(baseline, 3 and 12 months)
- major adverse cardiovascular events (MACE) - fatal and nonfatal(one year)