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Sponsors and Collaborators: |
Cedars-Sinai Medical Center National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | Cedars-Sinai Medical Center |
ClinicalTrials.gov Identifier: | NCT00570024 |
This research is being done because sudden and unexpected cardiac death remains a significant problem in patients with established coronary heart disease and accounts for 30% of deaths in this group (150,000 deaths annually) despite recognition and treatment of their heart disease. A large body of evidence implicates psychosocial stress as a risk factor and trigger for reduced blood flow in the heart, heart attack and sudden cardiac death, yet the specific mechanisms of this relationship remain under investigation. The nervous system, which plays a role in regulation of the heart, can influence cardiac arrhythmias (irregular heart beats). There are several studies that suggest that acupuncture improves anginal symptoms (like chest pain or tightness) and blood pressure, while reducing stress and improving overall quality of life. The reason that acupuncture seems to have a positive effect on these factors is thought to be that it helps the arteries and the nervous system to work better.
It is possible to measure these effects in a systematic way. The functioning of the artery can be measured by Peripheral Arterial Tonometry, (PAT) a simple monitoring device that measures blood flow using finger probes and a blood pressure cuff. Changes in the nervous system can be measured by using a 24-hour Holter monitor to record the heart rate. The 24-hour Holter monitor will also show if oxygen flow to the heart is decreased, as would happen during stress, by recording a continuous electrocardiogram (ECG). Feelings about stress can be established by questionnaires.
The purpose of this study is to compare three groups of people with known coronary heart disease. One group will receive traditional acupuncture, one group will receive alternative acupuncture, and a third group will receive usual care only.
Condition | Intervention | Phase |
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Coronary Artery Disease |
Procedure: Traditional Acupuncture Procedure: AA Other: Waiting group |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease |
Estimated Enrollment: | 145 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | August 2009 |
Arms | Assigned Interventions |
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TA: Active Comparator
Active TA
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Procedure: Traditional Acupuncture
In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
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AA |
Procedure: AA
In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
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Waiting Group: No Intervention |
Other: Waiting group
No intervention
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joan Kirschner, RN | 310-423-9667 | joan.kirschner@cshs.org |
Contact: Ying Mou, MEd | 310-423-9678 | mouy@cshs.org |
United States, California | |
Mark Goodson Building | Recruiting |
Los Angeles, California, United States, 90048 | |
Principal Investigator: Noel Bairey-Merz, MD | |
Sub-Investigator: Donna Polk, MD |
Principal Investigator: | Noel Bairey-Merz, MD | Cedars-Sinai Medical Center |
Responsible Party: | Cedars Sinai Medical Center ( Joanne Lazzaro ) |
Study ID Numbers: | IRB# 7320, 1 R01 AT001482 |
Study First Received: | December 7, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00570024 |
Health Authority: | United States: Institutional Review Board |
Acupuncture Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Cardiovascular Diseases |