Back to resultsA Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks (CCR)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cardiac Rehabilitation plus Transcendental Meditation
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring transcendental meditation, cardiac rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Columbia University Medical Center, Dept of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cardiac Rehabilitation plus Transcendental Meditation
Cardiac Rehabilitation
Arm Description
a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
This control is a standard Cardiac Rehabilitation without a stress reduction technique
Outcomes
Primary Outcome Measures
coronary blood flow as measured by PET
Secondary Outcome Measures
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)
Full Information
NCT ID
NCT01810029
First Posted
April 18, 2012
Last Updated
March 11, 2013
Sponsor
Maharishi International University
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT01810029
Brief Title
A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks
Acronym
CCR
Official Title
A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi International University
Collaborators
Columbia University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
transcendental meditation, cardiac rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Rehabilitation plus Transcendental Meditation
Arm Type
Experimental
Arm Description
a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
Arm Title
Cardiac Rehabilitation
Arm Type
Active Comparator
Arm Description
This control is a standard Cardiac Rehabilitation without a stress reduction technique
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Rehabilitation plus Transcendental Meditation
Other Intervention Name(s)
TM technique, TM program, Transcendental Meditation
Intervention Description
The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease
Primary Outcome Measure Information:
Title
coronary blood flow as measured by PET
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Schneider, M.D.
Organizational Affiliation
Maharishi International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center, Dept of Cardiology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31529385
Citation
Bokhari S, Schneider RH, Salerno JW, Rainforth MV, Gaylord-King C, Nidich SI. Effects of cardiac rehabilitation with and without meditation on myocardial blood flow using quantitative positron emission tomography: A pilot study. J Nucl Cardiol. 2021 Aug;28(4):1596-1607. doi: 10.1007/s12350-019-01884-9. Epub 2019 Sep 16.
Results Reference
derived
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A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks
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