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

NCT01810029 | Unknown Phase 2 DMC

• 1 other identifier: 1RC1HL100386-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

transcendental meditation; cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• coronary blood flow as measured by PET

  12 weeks

Secondary Outcomes (1)

• blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)

  12 weeks

Study Arms (2)

Cardiac Rehabilitation plus Transcendental Meditation

EXPERIMENTAL

a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program

Behavioral: Cardiac Rehabilitation plus Transcendental Meditation

Cardiac Rehabilitation

ACTIVE COMPARATOR

This control is a standard Cardiac Rehabilitation without a stress reduction technique

Behavioral: Cardiac Rehabilitation plus Transcendental Meditation

Interventions

Cardiac Rehabilitation plus Transcendental Meditation BEHAVIORAL

The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease

Also known as: TM technique, TM program, Transcendental Meditation

Cardiac Rehabilitation; Cardiac Rehabilitation plus Transcendental Meditation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maharishi International University: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University Medical Center, Dept of Cardiology

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 31529385 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cardiac Rehabilitation; Meditation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Robert H Schneider, M.D.

  Maharishi International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Natural Medicine and Prevention

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: March 13, 2013
• Study Start: October 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 13, 2013

Record last verified: 2012-04

Locations

US (1)