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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Maharishi University of Management.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Robert Schneider, MD, Maharishi University of Management
ClinicalTrials.gov Identifier:
NCT01810029
First received: April 18, 2012
Last updated: March 11, 2013
Last verified: April 2012

April 18, 2012
March 11, 2013
October 2009
April 2013   (final data collection date for primary outcome measure)
coronary blood flow as measured by PET [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01810029 on ClinicalTrials.gov Archive Site
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks
A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Coronary Artery Disease
Behavioral: 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
Other Name: TM technique, TM program, Transcendental Meditation
  • Experimental: Cardiac Rehabilitation plus Transcendental Meditation
    a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
    Intervention: Behavioral: Cardiac Rehabilitation plus Transcendental Meditation
  • Active Comparator: Cardiac Rehabilitation
    This control is a standard Cardiac Rehabilitation without a stress reduction technique
    Intervention: Behavioral: Cardiac Rehabilitation plus Transcendental Meditation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
May 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01810029
1RC1HL100386-01
Yes
Robert Schneider, MD, Maharishi University of Management
Maharishi University of Management
Columbia University
Principal Investigator: Robert H Schneider, M.D. Maharishi University of Management
Maharishi University of Management
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP