- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010738
Effects of Meditation on Mechanism of Coronary Heart Disease
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
To study the effects of Transcendental Meditation on Coronary Heart Disease
Study Overview
Detailed Description
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).
Study Type
Interventional
Enrollment
145
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
- Preventive and Rehabilitative Cardiac Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: C. Noel Bairey Merz, M.D., Preventive and Rehabilitative Cardiac Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Study Completion
August 1, 2002
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01 AT000226-01M
- R01AT000226-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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