The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease
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Purpose
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 |
|---|---|---|
|
Coronary Artery Disease |
Procedure: Traditional Acupuncture Procedure: AA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease |
- Heart Rate Variability (HRV) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Holter monitoring will be recorded during the provocative procedures and during a 24-hour period during which subjects will document their activities and any anginal symptoms in a diary.
| Enrollment: | 145 |
| Study Start Date: | January 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: TA
Active TA
|
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.
Other Name: Traditional Acupuncture
|
| 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.
Other Name: Alternative Acupuncture
|
| No Intervention: Waiting Group |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 21 years
- Male or female
- Local residence
- Medically able to participate
- CAD by MI, CABG, PTCA, or stroke (>3 months prior), or angiographic evidence >50% epicardial coronary artery stenosis in at least one coronary artery
- Consent and referring MD approval
Exclusion Criteria:
- Comorbid disease precluding survival during study
- MI, unstable angina, CABG, PTCA or stroke within 3 months*
- HIV infection, chronic or active hepatitis or other blood-borne illness
- Cognitive, psychological or substance abuse-related impairment, as clinically assessed
- Atrial fibrillation, predominant pacemaker rhythm, significant conduction system disease, or automatic internal defibrillator*
- Significant valvular heart disease*
- Class III or IV heart failure*
- Renal or liver failure, as clinically assessed
- Participating in TA, or formal psychosocial stress management program
- Participation in another trial.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00570024
| United States, California | |
| Cedars-Sinai Women's Heart Center | |
| Los Angeles, California, United States, 90048 | |
| Principal Investigator: | Noel Bairey-Merz, MD | Cedars-Sinai Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Noel Bairey Merz, Director, Cedars-Sinai Medical Center |
| ClinicalTrials.gov Identifier: | NCT00570024 History of Changes |
| Other Study ID Numbers: | IRB# 7320, 1 R01 AT001482 |
| Study First Received: | December 7, 2007 |
| Last Updated: | August 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cedars-Sinai Medical Center:
|
Acupuncture Coronary Artery Disease |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia |
Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 25, 2015