Clinical trial NCT05642936: RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men
Official title: A Randomized Controlled Trial of Meditation and Health Education on Carotid Intima-Media Thickness and Major Adverse Cardiovascular Events in Black Women and Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: College of Medicine, Charles R. Drew University of Medicine and Science
name: Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
First posted: 2022-12-08
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a randomized controlled community-based clinical trial
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Carotid Intima Medial Thickness (CIMT)
timeFrame: 12 months
Secondary outcomes:
measure: blood pressure
timeFrame: baseline, 3 and 12 months
measure: lipid profile
timeFrame: baseline and 12 months
measure: lifestyle factors
timeFrame: baseline, 3 and 12 months
measure: major adverse cardiovascular events (MACE) - fatal and nonfatal
timeFrame: one year
measure: major adverse cardiovascular events (MACE) - fatal
timeFrame: 12 years
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi International University
name: Robert H Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References: