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

Rheumatic Valve Disease Clinical Trial

Official title:

Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00732459
• Other study ID #: XJ-20080808
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 9, 2008
• Last updated: August 15, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: August 2008
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rheumatic Valve Disease

Intervention

Device:
• Electro-acupuncture preconditioning
electro-acupuncture

Locations

Country	Name	City	State
China	Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late loss		12 months	No