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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Xijing Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00732459
First Posted: August 12, 2008
Last Update Posted: August 18, 2008
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.
Collaborator:
Fourth Military Medical University
Information provided by:
Xijing Hospital
August 9, 2008
August 12, 2008
August 18, 2008
January 2007
July 2008   (Final data collection date for primary outcome measure)
late loss [ Time Frame: 12 months ]
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
Not Provided
Not Provided
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.
 
Unknown status
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.
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00732459
XJ-20080808
Yes
Not Provided
Not Provided
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