Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment cardiac rehabilitation plus transcendental meditation
Phase phase 2
Sponsor Maharishi University of Management
Collaborator Columbia University
Start date October 2009
End date April 2013
Trial size 56 participants
Trial identifier NCT01810029, 1RC1HL100386-01

Summary

The overall hypothesis of this study is that a cardiac rehabilitation program with meditation will be more effective than cardiac rehabilitation alone in improving blood flow through the diseased coronary arteries in African Americans. For this purpose, 56 African American men and women with coronary heart disease will be randomly assigned either to standard cardiac rehabilitation plus the Transcendental Meditation program or to standard cardiac rehabilitation alone. The treatment period will be 12 weeks in length.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
cardiac rehabilitation plus transcendental meditation TM technique, TM program, Transcendental Meditation
The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease
(Active Comparator)
This control is a standard Cardiac Rehabilitation without a stress reduction technique
cardiac rehabilitation plus transcendental meditation TM technique, TM program, Transcendental Meditation
The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease

Primary Outcomes

Measure
coronary blood flow as measured by PET
time frame: 12 weeks

Secondary Outcomes

Measure
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)
time frame: 12 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Male or female 2. Age: No limitations 3. CHD documented by medical history of at least one of the following: a.acute myocardial infarction (MI) within the preceding 12 months b.coronary artery bypass surgery (CABG) c. percutaneous coronary intervention (PCI, PTCA)d. chronic stable angina 4. Written informed consent Exclusion Criteria: 1. noncardiac life threatening illness 2. Severe cognitive impairment or physical disability 3. History of major psychiatric disorder, i.e. psychosis, dementia, or substance abuse disorder within the past year. 4. Left ventricular ejection fraction less than 40% 5. Conditions that may be a contraindications to PET perfusion imaging with adenosine stress testing, including unstable angina or myocardial infarction in the past week, aortic stenosis, uncontrolled hypertension, uncontrolled atrial or ventricular arrhythmias, second-degree or higher atrio-ventricular block in the absence of a functioning pacemaker, baseline hypotension (systolic blood pressure < 90 mm Hg), severe obstructive lung disease or decompensated heart failure.

Additional Information

Official title A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans
Principal investigator Robert H Schneider, M.D.
Description The overall objective of this study is to conduct a randomized controlled trial to determine the efficacy of cardiac rehabilitation with and without a structured, standardized, and validated stress reduction component in the secondary prevention of coronary heart disease (CHD) in African Americans. In this phase II trial, 56 African American men and women with established CHD will be randomly allocated either to standard cardiac rehabilitation with formal stress reduction training using the Transcendental Meditation program or to standard cardiac rehabilitation alone. The intervention period will be 12 weeks. At baseline and posttest, subjects will be tested by quantitative Positron Emission Tomography (PET) for myocardial perfusion and ischemia. Secondary outcomes comprise physiological, behavioral and psychosocial risk factors for CHD. The field site will be Columbia University Medical Center and the coordinating center will be MUMRI-Center for Natural Medicine and Prevention.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Maharishi University of Management.