RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men

Cardiovascular Disease Clinical Trial

— SR-CIMT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642936
• Other study ID #: HL51519B
• Status: Completed
• Phase: N/A
• Start date: October 2000
• Est. completion date: December 31, 2014

Study information

• Verified date: January 2024
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 31, 2014
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• didactic health education control
didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component
• Transcendental Meditation technique
a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maharishi International University	Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, College of Medicine, Charles R. Drew University of Medicine and Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima Medial Thickness (CIMT)	This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography	12 months
Secondary	blood pressure	systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit.	baseline, 3 and 12 months
Secondary	lipid profile	blood tests or panel for cholesterol, LDL, HDL, and triglycerides	baseline and 12 months
Secondary	lifestyle factors	diet, exercise and substance use	baseline, 3 and 12 months
Secondary	major adverse cardiovascular events (MACE) - fatal and nonfatal	adverse clinical events - fatal and non-fatal	one year
Secondary	major adverse cardiovascular events (MACE) - fatal	deaths	12 years