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

Sponsors and Collaborators:	Xijing Hospital Fourth Military Medical University
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00732459

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

MedlinePlus related topics: Acupuncture

U.S. FDA Resources

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

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

late loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
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

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

Keywords provided by Xijing Hospital:

myocardial protection
cardiac surgery
heart valve replacement

Study placed in the following topic categories:

Rheumatic Diseases

ClinicalTrials.gov processed this record on January 14, 2009