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Coronary Heart DiseasePhase 2MilwNCT01299935

A Randomized Controlled Trial of Stress Reduction on Cardiovascular Morbidity and Mortality in African Americans

A Phase 2 study testing Transcendental Meditation and Health Education in people with Coronary Heart Disease and Cardiovascular Disease, run by Maharishi International University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Read more about this study

Who is it for?
Any age
What is being tested?
Transcendental Meditation and Health Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteUnited States
Study dates
Jan 1998to Jul 2007
Phase
Phase 2
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • African American men and women with documented coronary heart disease defined a coronary angiogram demonstrating the presence of one more coronary arteries with > or = 50% stenosis.

Who cannot join

  • acute MI, stroke or coronary revascularization within the previous three months; symptomatic heart failure with EF < 20%; dementia or other cognitive impairment determined clinically; and non-cardiac life threatening illness.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Stress Reduction and Cardiovascular Disease Morbidity and Mortality

This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.

Read the detailed description

The overall objective of this randomized controlled trial is to conduct a long-term evaluation of the effects of the Transcendental Meditation (TM) program compared to health education (HE) on secondary prevention of clinical events in African American men and women with coronary artery disease (CAD). Patients (N=201; mean age 59 yrs) were enrolled with documented CAD (i.e., coronary angiogram showing at least one artery with > 50% stenosis). Patients were pretested at baseline and every 6-12 months for the duration of the study for incidence of clinical events, BP, BMI, medication usage, lifestyle behaviors, psychosocial stress factors and intervention compliance. Subjects were followed for a maximum of 9.2 years (mean 5.4 years). The investigators hypothesize that a selected stress reduction intervention, the TM program compared with a health education control may significantly reduce risk for death, myocardial infarction (MI) and stroke in African American men and women with CHD. If successful, the Transcendental Meditation program may be clinically useful in the secondary prevention of cardiovascular disease in a high-risk population.

Being tested
Transcendental Meditation, Health Education
Keywords
stress reduction, Transcendental Meditation technique, secondary prevention of coronary heart disease
Medical subject headings
Coronary Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcendental MeditationBehavioural

    Also called Transcendental Meditation technique, TM technique

    The Transcendental Meditation program is the principal mind-body approach of Maharishi Ayurveda, originating from the ancient Vedic tradition and introduced 50 years ago by Vedic scholar and teacher Maharishi Mahesh Yogi. The Transcendental Meditation technique is described as a simple and natural procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. Practice of the Transcendental Meditation technique does not require any changes in personal beliefs, philosophy or lifestyle. During the practice a unique state of restful alertness is gained. Acute and chronic physiological effects have been documented. The course is taught by instructors certified by Maharishi Foundation - USA.

  • Health EducationBehavioural

    Also called lifestyle modification

    health education is taught in a clinical setting using standard AHA recommendations for proper diet, exercise and control of substance usage but without a stress management component.

Study groups in NCT01299935
Study groupRoleWhat they receive
Stress reductionExperimentalStress reduction program utilizing the Transcendental Meditation (TM) technique
Receives: Behavioral: Transcendental Meditation
health educationActive comparatorhealth education is taught in a clinical setting using standard AHA recommendations for proper diet, exercise and control of substance usage but without a stress management component.
Receives: Behavioral: Health Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke

    Measured: every six months for an average of 5.4 years

Secondary outcomes (4)

  1. composite of cardiovascular mortality, nonfatal MI, nonfatal stroke, coronary revascularization, and hospitalization for heart failure, unstable angina or ischemic heart disease - non-MI.

    Measured: every six months for average of 5.4 years

  2. psychosocial distress factors

    psychometric factors included depression, hostility and anger using standardized psychometric instruments - Center for Epidemiological Depression Scale (CES-D), Cook-Medley Hostility Inventory (Ho), Anger Expression Scale (AX)

    Measured: annually for an average of 5.4 years

  3. blood pressure

    BP was assessed by standard clinical trial technique using multiple seated measurements in the research clinic

    Measured: every six months for an average of 5.4 years

  4. behavioral and lifestyle factors

    smoking, alcohol use, physical activity and dietary patterns were assessed by standard questionnaire. Body mass index was measured by balance and scale.

    Measured: annually for an average of 5.4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2011 (estimated)
  2. Study startJan 1998
  3. Primary completionJun 2007
  4. Study completionJul 2007

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01299935
Sponsor's protocol ID
R01HL048107
Acronym
Milw
Status last verified
Apr 2022
First submitted
18 Feb 2011
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Schneider RH, Grim CE, Rainforth MV, Kotchen T, Nidich SI, Gaylord-King C, Salerno JW, Kotchen JM, Alexander CN. Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks. Circ Cardiovasc Qual Outcomes. 2012 Nov;5(6):750-8. doi: 10.1161/CIRCOUTCOMES.112.967406. Epub 2012 Nov 13.

    PubMed 23149426

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcendental Meditation and Health Education in people with Coronary Heart Disease and Cardiovascular Disease, run by Maharishi International University at 1 site in United States.

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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (time frame: every six months for an average of 5.4 years). 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 NCT01299935, 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 14 Apr 2022.

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