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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
History of Changes
  Purpose

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


Condition Intervention
Rheumatic Valve Disease
 Device: Electro-acupuncture preconditioning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • late loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
electro-acupuncture preconditioning group
 Device: Electro-acupuncture preconditioning
electro-acupuncture
Other Names:
  • Huatuo Brand
  • Type SDZ-II
2
control group

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732459

Locations
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
Investigators
Study Chair: Lize Xiong, M.D. Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lize Xiong / Director of Department of Anasthesiology of Xijing Hospital, Xijing Hospital of Fourth Military Military Medical University
ClinicalTrials.gov Identifier: NCT00732459     History of Changes
Other Study ID Numbers: XJ-20080808
Study First Received: August 9, 2008
Last Updated: August 15, 2008
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 16, 2013