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

• Conditions: Rheumatic Valve Disease
• Interventions: Device: Electro-acupuncture preconditioning

• Registration Number: NCT00732459
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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 Timeline

• Study Start: 2007-01
• Primary Completion: 2008-07
• Status Verified: 2008-08
• Study First Submitted: 2008-08-09
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Last Update Submitted: 2008-08-15
• Last Update Posted: 2008-08-18
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Electro-acupuncture preconditioning	electro-acupuncture preconditioning group

Primary Outcome Measures

Name	Time	Method
late loss	12 months

Trial Locations

Locations (1)

Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China