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The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease
This study is currently recruiting participants.
Verified by Cedars-Sinai Medical Center, December 2007
Sponsors and Collaborators: Cedars-Sinai Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00570024
  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
Other: Waiting group
Phase III

MedlinePlus related topics: Acupuncture Coronary Artery Disease Heart Diseases
U.S. FDA Resources
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

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Holter Monitor Heart Rate Variability (HRV) Testing: 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. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • In addition to the 24-hour HRV, two provocative tests will be used to evaluate the influence of PNS and SNS on HRV. [ Time Frame: 50 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychosocial variables, CHD symptoms and Functional status, and Demographic Variable Measurement [ Time Frame: 45 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 145
Study Start Date: January 2006
Estimated Study Completion Date: August 2009
Arms Assigned Interventions
TA: Active Comparator
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.
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.
Waiting Group: No Intervention Other: Waiting group
No intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570024

Contacts
Contact: Joan Kirschner, RN 310-423-9667 joan.kirschner@cshs.org
Contact: Ying Mou, MEd 310-423-9678 mouy@cshs.org

Locations
United States, California
Mark Goodson Building Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Noel Bairey-Merz, MD            
Sub-Investigator: Donna Polk, MD            
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Noel Bairey-Merz, MD Cedars-Sinai Medical Center
  More Information

Publications:
Bots ML, Westerink J, Rabelink TJ, de Koning EJ. Assessment of flow-mediated vasodilatation (FMD) of the brachial artery: effects of technical aspects of the FMD measurement on the FMD response. Eur Heart J. 2005 Feb;26(4):363-8. Epub 2004 Dec 1. Review.
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41.
Bonetti PO, Barsness GW, Keelan PC, Schnell TI, Pumper GM, Kuvin JT, Schnall RP, Holmes DR, Higano ST, Lerman A. Enhanced external counterpulsation improves endothelial function in patients with symptomatic coronary artery disease. J Am Coll Cardiol. 2003 May 21;41(10):1761-8.
Chouraqui P, Schnall RP, Dvir I, Rozanski A, Qureshi E, Arditti A, Saef J, Feigin PD, Sheffy J. Assessment of peripheral artery tonometry in the detection of treadmill exercise-induced myocardial ischemia. J Am Coll Cardiol. 2002 Dec 18;40(12):2195-200.
Goor DA, Sheffy J, Schnall RP, Arditti A, Caspi A, Bragdon EE, Sheps DS. Peripheral arterial tonometry: a diagnostic method for detection of myocardial ischemia induced during mental stress tests: a pilot study. Clin Cardiol. 2004 Mar;27(3):137-41.
Moens AL, Goovaerts I, Claeys MJ, Vrints CJ. Flow-mediated vasodilation: a diagnostic instrument, or an experimental tool? Chest. 2005 Jun;127(6):2254-63. Review.
von Mering GO, Arant CB, Wessel TR, McGorray SP, Bairey Merz CN, Sharaf BL, Smith KM, Olson MB, Johnson BD, Sopko G, Handberg E, Pepine CJ, Kerensky RA; National Heart, Lung, and Blood Institute. Abnormal coronary vasomotion as a prognostic indicator of cardiovascular events in women: results from the National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE). Circulation. 2004 Feb 17;109(6):722-5.

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

Keywords provided by Cedars-Sinai Medical Center:
Acupuncture
Coronary Artery Disease

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009