Effects of Meditation on Mechanism of Coronary Heart Disease

Phase 2

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT00010738
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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).

Study Timeline

• Study Start: 1999-09
• Study First Submitted: 2001-02-02
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Study Completion: 2002-08
• Status Verified: 2006-07
• Last Update Submitted: 2006-08-17
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Preventive and Rehabilitative Cardiac Center; 🇺🇸 Los Angeles, California, United States