A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cardiac Rehabilitation plus Transcendental Meditation

a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program

Group Type EXPERIMENTAL

Cardiac Rehabilitation plus Transcendental Meditation

Intervention Type BEHAVIORAL

The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease

Cardiac Rehabilitation

This control is a standard Cardiac Rehabilitation without a stress reduction technique

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation plus Transcendental Meditation

Intervention Type BEHAVIORAL

The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease

Interventions

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Cardiac Rehabilitation plus 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

Intervention Type BEHAVIORAL

Other Intervention Names

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TM technique, TM program, Transcendental Meditation

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No