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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
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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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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