Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732459
Recruitment Status : Unknown
Verified August 2008 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : August 12, 2008
Last Update Posted : August 18, 2008
Fourth Military Medical University
Information provided by:
Xijing Hospital

Brief Summary:
The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.

Condition or disease Intervention/treatment
Rheumatic Valve Disease Device: Electro-acupuncture preconditioning

Detailed Description:
Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Group/Cohort Intervention/treatment
electro-acupuncture preconditioning group
Device: Electro-acupuncture preconditioning
Other Names:
  • Huatuo Brand
  • Type SDZ-II
control group

Primary Outcome Measures :
  1. late loss [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.

Inclusion Criteria:

  • patients who have the indication for aortic or mitral valve replacement
  • patients would like to accept the follow-up and sign the informed consent
  • patients with heart function of NYHA I-III degree.

Exclusion Criteria:

  • pregnant or nursing women
  • comorbid with coronary artery disease
  • patients with heart function of NYHA IV degree
  • renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
  • anticipated life span < 12 months
  • enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732459

China, Shaanxi
Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
Study Chair: Lize Xiong, M.D. Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lize Xiong / Director of Department of Anasthesiology of Xijing Hospital, Xijing Hospital of Fourth Military Military Medical University Identifier: NCT00732459     History of Changes
Other Study ID Numbers: XJ-20080808
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

Keywords provided by Xijing Hospital:
myocardial protection
cardiac surgery
heart valve replacement