Coronary Artery Disease
Conditions
Keywords
transcendental meditation, cardiac rehabilitation
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.
Interventions
BEHAVIORALCardiac 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
Sponsors
Columbia University
Maharishi International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| coronary blood flow as measured by PET | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being) | 12 weeks |
Countries
United States
Outcome results
None listed