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| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | November 6, 2007 | ||||
| Start Date ICMJE | September 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00010530 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Basic Mechanisms of Meditation and Cardiovascular Disease in Older Blacks | ||||
| Official Title ICMJE | Basic Mechanisms of Meditation and Cardiovascular Disease in Older Blacks | ||||
| Brief Summary | The purpose of this study is to evaluate the effects of meditation on older African Americans with documented cardiovascular disease (CVD). |
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| 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. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind | ||||
| Condition ICMJE | Cardiovascular Diseases | ||||
| Intervention ICMJE | Procedure: Meditation | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | July 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00010530 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P50 AT000082-01P1, P50AT000082-01, P50AT000082-02 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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