MedDataX Logo

Effects of Meditation on Mechanism of Coronary Heart Disease

NCT ID: NCT00010738

Last Updated: 2006-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2002-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To study the effects of Transcendental Meditation on Coronary Heart Disease

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Recent advances in our understanding of the pathophysiology of acute cardiac events - specifically, identification of the roles that arterial vasomotor dysfunction and autonomic nervous system imbalances play in the pathophysiologic cascade during such acute events - provides a platform for new mechanistic investigation of the interplay of psychosomatic stress and CHD (coronary heart disease). Preliminary evidence further suggests that Complementary and Alternative Medicine (CAM) practices, such as the Transcendental Meditation (TM) technique, can not only reduce stress but also reduce acute cardiac events in patients with CHD. Based on these and related data, we propose a randomized, blinded, controlled study of the effects of one CAM practice, the TM technique, compared to a control group, on the primary outcomes of (1) arterial vasomotor dysfunction (brachial artery reactivity); (2) autonomic nervous system imbalances (heart rate variability); (3) transient myocardial ischemia (ST-segment depression); and (4) the secondary outcomes of psychological stress and quality of life (anger, hostility, anxiety, depression, perceived health, disease-specific symptoms, and life stress/social resources).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meditation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Able to attend training sessions and meetings
* Local residence

Exclusion Criteria

* Comorbid disease precluding survival in group
* MI, unstable angina, CABG or PTCA within last three months.
* Cognitive/psychological/substance abuse impairment
* Atrial fibrillation, predominant pacemaker rhythm or significant conduction system disease
* Significant valvular heart disease
* Class III or IV heart failure
* Renal failure
* Participating in a formal stress management program
* Participation in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

C. Noel Bairey Merz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Preventive and Rehabilitative Cardiac Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Preventive and Rehabilitative Cardiac Center

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01AT000226-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 AT000226-01M

Identifier Type: -

Identifier Source: org_study_id

NCT00009399

Identifier Type: -

Identifier Source: nct_alias