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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Behavioral: Cardiac Rehabilitation plus Transcendental Meditation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans

Resource links provided by NLM:


Further study details as provided by Maharishi University of Management:

Primary Outcome Measures:
  • coronary blood flow as measured by PET [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 56
Study Start Date: October 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac Rehabilitation plus Transcendental Meditation
a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program
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
Active Comparator: Cardiac Rehabilitation
This control is a standard Cardiac Rehabilitation without a stress reduction technique
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810029

Locations
United States, New York
Columbia University Medical Center, Dept of Cardiology
New York, New York, United States, 10032
Sponsors and Collaborators
Maharishi University of Management
Columbia University
Investigators
Principal Investigator: Robert H Schneider, M.D. Maharishi University of Management
  More Information

No publications provided

Responsible Party: Robert Schneider, MD, Director, Center for Natural Medicine and Prevention, Maharishi University of Management
ClinicalTrials.gov Identifier: NCT01810029     History of Changes
Other Study ID Numbers: 1RC1HL100386-01
Study First Received: April 18, 2012
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Maharishi University of Management:
transcendental meditation
cardiac rehabilitation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014