The Effects of Traditional Acupuncture on Mechanisms of Coronary Heart Disease

April 8, 2019 updated by: Noel Bairey Merz, Cedars-Sinai Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A. SPECIFIC AIMS Sudden and unexpected cardiac death remains a significant problem in patients with established coronary heart disease (CHD), and accounts for 30% of deaths in this group (~150,000 deaths annually) despite recognition and treatment of their disease. These sudden deaths are due to myocardial infarction and ischemic or nonischemically mediated arrythmias. Traditional risk factors do not completely account for the excess of CHD deaths. Although treatment of cardiac risk factors, such as hyperlipidemia, has been shown to significantly reduce cardiac events in populations with established coronary heart disease (e.g. by 34% in the Scandinavian Simvastatin Survival Study1) a majority of patients continue to have sudden and unexpected cardiac events including sudden cardiac death. Indeed, up to 50% of patients with established CHD will have recurrent events despite aggressive management of traditional risk factors such as hyperlipidemia, tobacco use and hypertension. This suggests that additional risk factors or mechanisms participate in the pathophysiological cascade underlying acute CHD events.

A large body of evidence implicates psychosocial stress as a risk factor and trigger for myocardial ischemia, infarction and sudden cardiac death, yet the specific mechanisms(s) of this relationship remain under investigation.2-9 The mechanisms may include hemodynamic, hemostatic and neuronally mediated effects on the cardiovascular system. Specifically they may include a prominent role of the cardiac autonomic nervous system, including the sympathetic nervous system (SNS) and parasympathetic nervous system (PNS).10 Indeed, cardiac arrhythmias have been implicated both as a risk factor and an etiology for sudden cardiac death, suggesting that alteration of cardiac autonomic nervous system tone may provide an opportunity for reducing acute cardiac events and sudden cardiac death. Prior work by ourselves and others has also demonstrated that sympathetic activation from psychosocial stress results in vascular constriction that, in the presence of impaired nitric oxide (NO) production and endothelial dysfunction, contributes to myocardial ischemia and adverse cardiac events, including sudden death. 6,8,11-15 Traditional Acupuncture (TA) is a Complementary and Alternative Medicine (CAM) practice with documented effects of improving physiologic imbalances and reducing psychosocial stress. For example, the TA technique has been shown, to significantly reduce mental stress in humans16, hypertension in an animal model17 and angina pectoris in CHD patients.18 These changes are consistent with the hypothesis that the TA technique directly alters autonomic nervous system tone, likely by reducing SNS activity, and possibly also by increasing PNS activity. We also hypothesize that TA may beneficially alter CHD indirectly by reducing psychosocial stress. Either of these hypotheses suggests that this CAM practice may serve as a complement or alternative to medical treatment for the prevention of acute cardiac events and sudden cardiac death.

We propose to evaluate the effect of TA on arterial vasomotor function and autonomic nervous system tone, two physiologic variables involved in the pathophysiological cascade underlying acute cardiac events and sudden death in CHD patients. To test for both the hypothesized direct and indirect effects of this CAM modality, we propose to compare an active TA intervention to two control groups: 1) an Alternative Acupuncture control group, and 2) a waiting control group, in patients with CHD.

Primary Aim

  1. To assess effects of the TA technique (compared to Alternative Acupuncture and waiting control) on cardiac autonomic nervous system tone, as measured by heart rate variability (HRV) using Holter monitoring.

    Secondary Aims

  2. To assess effects of the TA technique (compared to Alternative Acupuncture and waiting control) on CHD variables including a marker of inflammation (high sensitivity C reactive protein), symptoms (Seattle Angina Questionnaire), functional status (Duke Activity Status Inventory), blood lipoproteins, and blood pressure.

  3. To assess effects of the TA technique (compared to Alternative Acupuncture and waiting control) on measures of perceived psychological stress, depression, hostility, anxiety, social support, and quality of life.

    Exploratory Aims

  4. To estimate effect size of the TA technique (compared to Alternative Acupuncture and waiting control) on arterial vasomotor dysfunction, as measured by mental stress-brachial artery reactivity testing (BART) using high frequency ultrasound.

The results of the study will: a) provide an improved understanding of the hypothesized beneficial physiological and psychological effects of this CAM practice, and b) serve as potential pilot data for a multi-center TA proposal to evaluate the impact of TA on acute cardiac events, including sudden cardiac death.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Women's Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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 Names:
  • Alternative Acupuncture
No Intervention: Waiting Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability (HRV)
Time Frame: 24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Noel Bairey-Merz, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 7320
  • 1R01AT001482 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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