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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT00732459
First received: August 9, 2008
Last updated: August 15, 2008
Last verified: August 2008

August 9, 2008
August 15, 2008
January 2007
July 2008   (final data collection date for primary outcome measure)
late loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00732459 on ClinicalTrials.gov Archive Site
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Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery
Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.

Rheumatic Valve Disease
Device: Electro-acupuncture preconditioning
electro-acupuncture
Other Names:
  • Huatuo Brand
  • Type SDZ-II
  • 1
    electro-acupuncture preconditioning group
    Intervention: Device: Electro-acupuncture preconditioning
  • 2
    control group
Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
December 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00732459
XJ-20080808
Yes
Lize Xiong / Director of Department of Anasthesiology of Xijing Hospital, Xijing Hospital of Fourth Military Military Medical University
Xijing Hospital
Fourth Military Medical University
Study Chair: Lize Xiong, M.D. Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University
Xijing Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP