Coronary Artery DiseasePhase 2CCRNCT01810029
A Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in Blacks
A Phase 2 study testing Cardiac Rehabilitation plus Transcendental Meditation in people with Coronary Artery Disease, run by Maharishi International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac Rehabilitation plus Transcendental Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to May 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center, Dept of Cardiology
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac Rehabilitation plus Transcendental Meditation
- Keywords
- transcendental meditation, cardiac rehabilitation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation plus Transcendental MeditationBehavioural
Also called TM technique, TM program, 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
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Rehabilitation plus Transcendental Meditation | Experimental | a standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program Receives: Behavioral: Cardiac Rehabilitation plus Transcendental Meditation |
| Cardiac Rehabilitation | Active comparator | This control is a standard Cardiac Rehabilitation without a stress reduction technique Receives: Behavioral: Cardiac Rehabilitation plus Transcendental Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary blood flow as measured by PET
Measured: 12 weeks
Secondary outcomes (1)
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startOct 2009
- Primary completionApr 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Robert H Schneider, M.D., Principal investigator, Maharishi International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810029
- Sponsor's protocol ID
- 1RC1HL100386-01
- Acronym
- CCR
- Status last verified
- Apr 2012
- First submitted
- 18 Apr 2012
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31529385
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Stress Reduction in the Secondary Prevention of Coronary Heart Disease in African Americans
- ClinicalTrials.gov ID
- NCT01810029
- Acronym / sponsor ID
- CCR / 1RC1HL100386-01
- Conditions
- Coronary Artery Disease
- Keywords
- transcendental meditation, cardiac rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Rehabilitation plus Transcendental Meditation | Experimental | Behavioral: Cardiac Rehabilitation plus Transcendental Meditationa standard validated cardiac rehabilitation program plus a standard validated stress reduction component, the Transcendental Meditation program |
| Cardiac Rehabilitation | Active comparator | Behavioral: Cardiac Rehabilitation plus Transcendental MeditationThis control is a standard Cardiac Rehabilitation without a stress reduction technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation plus Transcendental MeditationAlso: TM technique, TM program, Transcendental MeditationThe stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease | Behavioural | Cardiac Rehabilitation, Cardiac Rehabilitation plus Transcendental Meditation |
Primary outcome
coronary blood flow as measured by PET
Time frame: 12 weeks
1 secondary outcome
blood pressure, behavioral risk factors (diet, exercise, substance use) and psychosocial stress factors (depression, social support, general well-being)
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Derived from this study: PubMed 31529385Bokhari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Schneider, M.D. principal investigator
Maharishi International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiac Rehabilitation plus Transcendental Meditation in people with Coronary Artery Disease, run by Maharishi International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary blood flow as measured by PET (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01810029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.