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NCT00010738 Clinical Trial

Effects of Meditation on Mechanism of Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:
Effects of Meditation on Mechanism of Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00010738
Other study ID # R01 AT000226-01M
Secondary ID R01AT000226-01
Status Completed
Phase Phase 2
First received February 2, 2001
Last updated August 17, 2006
Start date September 1999
Est. completion date August 2002

Study information
Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To study the effects of Transcendental Meditation on Coronary Heart Disease

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).

Other known NCT identifiers
  • NCT00009399

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Meditation

Locations
Country Name City State
United States Preventive and Rehabilitative Cardiac Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

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