NCT00570024

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

4.2 years

First QC Date

December 7, 2007

Last Update Submit

April 8, 2019

Conditions

Coronary Artery Disease

Keywords

AcupunctureCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Heart Rate Variability (HRV)

    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

Study Arms (3)

TA

ACTIVE COMPARATOR

Active TA

Procedure: Traditional Acupuncture

AA

OTHER
Procedure: AA

Waiting Group

NO INTERVENTION

Interventions

Traditional AcupuncturePROCEDURE

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.

TA
AAPROCEDURE

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.

Also known as: Alternative Acupuncture
AA

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Related Publications (8)

  • 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. doi: 10.1093/eurheartj/ehi017. Epub 2004 Dec 1.

    PMID: 15618057BACKGROUND

  • 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. doi: 10.1016/j.jacc.2004.08.062.

    PMID: 15582310BACKGROUND

  • 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. doi: 10.1016/s0735-1097(03)00329-2.

    PMID: 12767662BACKGROUND

  • 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. doi: 10.1016/s0735-1097(02)02591-3.

    PMID: 12505234BACKGROUND

  • 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. doi: 10.1002/clc.4960270307.

    PMID: 15049379BACKGROUND

  • 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. doi: 10.1378/chest.127.6.2254.

    PMID: 15947345BACKGROUND

  • 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. doi: 10.1161/01.CIR.0000115525.92645.16.

    PMID: 14970106BACKGROUND

  • Mehta PK, Polk DM, Zhang X, Li N, Painovich J, Kothawade K, Kirschner J, Qiao Y, Ma X, Chen YD, Brantman A, Shufelt C, Minissian M, Merz CN. A randomized controlled trial of acupuncture in stable ischemic heart disease patients. Int J Cardiol. 2014 Sep 20;176(2):367-74. doi: 10.1016/j.ijcard.2014.07.011. Epub 2014 Jul 11.

    PMID: 25103909DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Noel Bairey-Merz, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 10, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations

US(1)