Effects of Meditation on Mechanism of Coronary Heart Disease
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility 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
Sites / Locations
- Preventive and Rehabilitative Cardiac Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010738
First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010738
Brief Title
Effects of Meditation on Mechanism of Coronary Heart Disease
Official Title
Effects of Meditation on Mechanism of Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
To study the effects of Transcendental Meditation on Coronary Heart Disease
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
145 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Meditation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Noel Bairey Merz, M.D.
Organizational Affiliation
Preventive and Rehabilitative Cardiac Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preventive and Rehabilitative Cardiac Center
City
Los Angeles
State/Province
California
Country
United States
12. IPD Sharing Statement
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Effects of Meditation on Mechanism of Coronary Heart Disease
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