A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- coronary blood flow as measured by PET
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female
- •Age: No limitations
- •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
- •Written informed consent
Exclusion Criteria
- •noncardiac life threatening illness
- •Severe cognitive impairment or physical disability
- •History of major psychiatric disorder, i.e. psychosis, dementia, or substance abuse disorder within the past year.
- •Left ventricular ejection fraction less than 40%
- •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.
Arms & Interventions
Cardiac Rehabilitation plus Transcendental Meditation
a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
Intervention: Cardiac Rehabilitation plus Transcendental Meditation (Behavioral)
Cardiac Rehabilitation
This control is a standard Cardiac Rehabilitation without a stress reduction technique
Intervention: Cardiac Rehabilitation plus Transcendental Meditation (Behavioral)
Outcomes
Primary Outcomes
coronary blood flow as measured by PET
Time Frame: 12 weeks
Secondary Outcomes
- blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)(12 weeks)
Investigators
Robert Schneider, MD
Director, Center for Natural Medicine and Prevention
Maharishi International University