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

A

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Rheumatic Valve Disease

Treatments

Device: Electro-acupuncture preconditioning

Study type

Observational

Funder types

Other

Identifiers

NCT00732459
XJ-20080808

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

1
Description:
electro-acupuncture preconditioning group
Treatment:
Device: Electro-acupuncture preconditioning
2
Description:
control group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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