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Effects of Meditation on Mechanism of Coronary Heart Disease

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ClinicalTrials.gov Identifier: NCT00010738
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
To study the effects of Transcendental Meditation on Coronary Heart Disease

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Procedure: Meditation Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Effects of Meditation on Mechanism of Coronary Heart Disease
Study Start Date : September 1999
Estimated Study Completion Date : August 2002

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Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010738


Locations
United States, California
Preventive and Rehabilitative Cardiac Center
Los Angeles, California, United States
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: C. Noel Bairey Merz, M.D. Preventive and Rehabilitative Cardiac Center
More Information

ClinicalTrials.gov Identifier: NCT00010738     History of Changes
Obsolete Identifiers: NCT00009399
Other Study ID Numbers: R01 AT000226-01M
R01AT000226-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases