- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00010530
Basic Mechanisms of Meditation and Cardiovascular Disease in Older Blacks
December 4, 2009 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to evaluate the effects of meditation on older African Americans with documented cardiovascular disease (CVD).
Study Overview
Detailed Description
Cardiovascular disease (CVD) is the leading cause of death and disability in older African Americans, and accounts for 40% of the disproportionate risk for mortality observed in African Americans compared to white Americans.
The majority of CVD patients experience acute cardiac events, many sudden and unexpected, despite conventional treatment of their disease and associated traditional risk factors.
The pathophysiologic basis of these cardiac events is not fully established, but substantial evidence indicates that psychosocial stress and the sympathetic nervous system have adverse effects on both vasomotor function and long-term autonomic balance.
Recent advances in the understanding of the pathophysiology of acute cardiac events-specifically, the roles that arterial vasomotor dysfunction and sympathetic nervous system imbalance play in the pathophysiology of such acute events-provide a platform for a new mechanistic investigation of the interplay of psychosocial and environmental stress and CVD.
Preliminary evidence demonstrating elevated peripheral vasoconstriction due to stress-mediated sympathetic nervous system response in African Americans further suggests that these mechanisms are particularly relevant in this group.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
- Charles R. Drew University of Medicine and Science
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Iowa
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Fairfield, Iowa, United States, 52557
- Maharishi University of Management Center for Health and Aging Studies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- African-American (self-identified)
- Local residence
- Able to participate
- Coronary artery disease by MI, CABG, PTCA (>3 months prior), or angiography
- Consent and referring MD approval
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert H. Schneider, MD, Center for Health and Aging Studies
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1999
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
February 2, 2001
First Submitted That Met QC Criteria
February 2, 2001
First Posted (Estimate)
February 5, 2001
Study Record Updates
Last Update Posted (Estimate)
December 7, 2009
Last Update Submitted That Met QC Criteria
December 4, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50AT000082-01P1 (U.S. NIH Grant/Contract)
- P50AT000082-01 (U.S. NIH Grant/Contract)
- P50AT000082-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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