Cardiovascular Disease
Conditions
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.
Interventions
BEHAVIORALdidactic health education control
didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component
BEHAVIORALTranscendental Meditation technique
a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting
Sponsors
College of Medicine, Charles R. Drew University of Medicine and Science
Barbara Streisand Women's' Heart Center, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
Maharishi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
All investigators and clinic staff were blinded to treatment assignment, except the project manager who did not collect data from participants. Primary care physicians were blinded to the treatment assignments of their patients. Since participants were necessarily aware of their treatment status.
Intervention model description
This was a randomized controlled community-based clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima Medial Thickness (CIMT) | 12 months | This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | baseline, 3 and 12 months | systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit. |
| lipid profile | baseline and 12 months | blood tests or panel for cholesterol, LDL, HDL, and triglycerides |
| lifestyle factors | baseline, 3 and 12 months | diet, exercise and substance use |
| major adverse cardiovascular events (MACE) - fatal and nonfatal | one year | adverse clinical events - fatal and non-fatal |
| major adverse cardiovascular events (MACE) - fatal | 12 years | deaths |
Outcome results
None listed