Cardiovascular DiseaseSR-CIMTNCT05642936
RCT of Meditation and Health Education on CIMT and MACE in Black Women and Men
A study testing Transcendental Meditation technique in people with Cardiovascular Disease, run by Maharishi International University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Transcendental Meditation technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- didactic health education control, Transcendental Meditation technique
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
didactic health education controlBehavioural
Also called lifestyle modification
didactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component
Transcendental Meditation techniqueBehavioural
Also called TM program
a mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation | Experimental | The TM technique is a simple, natural, effortless mental procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. During the practice, it is reported that ordinary thinking processes settle down, and a distinctive "wakeful hypometabolic" state characterized by neural coherence and physiological rest is gained. The TM technique was taught in a 7-step course of instruction consisting of six 1.5-2 hour individual and group meetings taught by a certified instructor. Receives: Behavioral: Transcendental Meditation technique |
| Health Education | Active comparator | The control intervention was a cardiovascular health education program designed to match the format of the experimental intervention for instructional time, instructor attention, participant expectancy, social support, and other nonspecific factors. The classroom content was based on standard, published materials. The instructors were professional health educators. Receives: Behavioral: didactic health education control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intima Medial Thickness (CIMT)
This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography
Measured: 12 months
Secondary outcomes (5)
blood pressure
systolic and diastolic BP technique. The three readings were taken one minute apart and then averaged for that visit.
Measured: baseline, 3 and 12 months
lipid profile
blood tests or panel for cholesterol, LDL, HDL, and triglycerides
Measured: baseline and 12 months
lifestyle factors
diet, exercise and substance use
Measured: baseline, 3 and 12 months
major adverse cardiovascular events (MACE) - fatal and nonfatal
adverse clinical events - fatal and non-fatal
Measured: one year
major adverse cardiovascular events (MACE) - fatal
deaths
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study startOct 2000
- Primary completionJul 2005
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized controlled community-based clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science, Cedars-Sinai Medical Center
- Responsible party
- Principal investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Robert H Schneider, M.D., Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642936
- Sponsor's protocol ID
- HL51519B
- Acronym
- SR-CIMT
- Status last verified
- May 2025
- First submitted
- 30 Nov 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request to the study investigators, an outside researcher may inquire for permission to obtain the IPD (deidentified) on an MS excel and Access databases.
Publications
Norris KC, Salerno J, Bairey Merz CN, Kaushik V, Gelleta S, Castillo A, Nidich S, Gaylord-King C, Schneider RH. A randomized controlled trial of meditation and health education on carotid intima-media thickness and major adverse cardiovascular events in Black men and women. Front Med (Lausanne). 2025 Mar 19;12:1513699. doi: 10.3389/fmed.2025.1513699. eCollection 2025.
PubMed 40177279
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05642936
- Acronym / sponsor ID
- SR-CIMT / HL51519B
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Collaborators
- Charles Drew University of Medicine and Science, Cedars-Sinai Medical Center
- Study start
- Oct 2000 (actual)
- Primary completion
- Jul 2005 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized controlled community-based clinical trial
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation | Experimental | Behavioral: Transcendental Meditation techniqueThe TM technique is a simple, natural, effortless mental procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. During the practice, it is reported that ordinary thinking processes settle down, and a distinctive "wakeful hypometabolic" state characterized by neural coherence and physiological rest is gained. The TM technique was taught in a 7-step course of instruction consisting of six 1.5-2 hour individual and group meetings taught by a certified instructor. |
| Health Education | Active comparator | Behavioral: didactic health education controlThe control intervention was a cardiovascular health education program designed to match the format of the experimental intervention for instructional time, instructor attention, participant expectancy, social support, and other nonspecific factors. The classroom content was based on standard, published materials. The instructors were professional health educators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| didactic health education controlAlso: lifestyle modificationdidactic classroom-based comparison group that follows standard guidelines for diet, exercise and substance use with no stress reduction component | Behavioural | Health Education |
| Transcendental Meditation techniqueAlso: TM programa mental technique derived from the Vedic tradition of ancient India and practiced by anyone for 20 minutes twice a day sitting | Behavioural | Transcendental Meditation |
Primary outcome
Carotid Intima Medial Thickness (CIMT)
Time frame: 12 months
This measure of wall thickness of the carotid artery was assessed by B-mode ultrasonography
5 secondary outcomes
blood pressure
Time frame: baseline, 3 and 12 months
lipid profile
Time frame: baseline and 12 months
lifestyle factors
Time frame: baseline, 3 and 12 months
major adverse cardiovascular events (MACE) - fatal and nonfatal
Time frame: one year
major adverse cardiovascular events (MACE) - fatal
Time frame: 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 40177279Norris KC, Salerno J, Bairey Merz CN, Kaushik V, Gelleta S, Castillo A, Nidich S, Gaylord-King C, Schneider RH. A randomized controlled trial of meditation and health education on carotid intima-media thickness and major adverse cardiovascular events in Black men and women. Front Med (Lausanne). 2025 Mar 19;12:1513699. doi: 10.3389/fmed.2025.1513699. eCollection 2025.
- Individual participant dataSharing planned: Yes. upon request to the study investigators, an outside researcher may inquire for permission to obtain the IPD (deidentified) on an MS excel and Access databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Schneider, M.D. principal investigator
Maharishi International University
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation technique in people with Cardiovascular Disease, run by Maharishi International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Intima Medial Thickness (CIMT) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.