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| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | August 17, 2006 | ||||
| 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 NCT00010738 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Meditation on Mechanism of Coronary Heart Disease | ||||
| Official Title ICMJE | Effects of Meditation on Mechanism of Coronary Heart Disease | ||||
| Brief Summary | To study the effects of Transcendental Meditation on Coronary Heart Disease |
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| Detailed Description | Recent advances in our understanding of the pathophysiology of acute cardiac events - specifically, identification of the roles that arterial vasomotor dysfunction and autonomic nervous system imbalances play in the pathophysiologic cascade during such acute events - provides a platform for new mechanistic investigation of the interplay of psychosomatic stress and CHD (coronary heart disease). Preliminary evidence further suggests that Complementary and Alternative Medicine (CAM) practices, such as the Transcendental Meditation (TM) technique, can not only reduce stress but also reduce acute cardiac events in patients with CHD. Based on these and related data, we propose a randomized, blinded, controlled study of the effects of one CAM practice, the TM technique, compared to a control group, on the primary outcomes of (1) arterial vasomotor dysfunction (brachial artery reactivity); (2) autonomic nervous system imbalances (heart rate variability); (3) transient myocardial ischemia (ST-segment depression); and (4) the secondary outcomes of psychological stress and quality of life (anger, hostility, anxiety, depression, perceived health, disease-specific symptoms, and life stress/social resources). |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE | Coronary Heart Disease | ||||
| 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 | 145 | ||||
| Completion Date | August 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 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 | NCT00010738 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 AT000226-01M, R01 AT000226-01 | ||||
| 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 | July 2006 | ||||
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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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