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

NCT ID: NCT00732459

Last Updated: 2008-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatic Valve Disease

Keywords

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myocardial protection cardiac surgery heart valve replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

electro-acupuncture preconditioning group

Electro-acupuncture preconditioning

Intervention Type DEVICE

electro-acupuncture

2

control group

No interventions assigned to this group

Interventions

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Electro-acupuncture preconditioning

electro-acupuncture

Intervention Type DEVICE

Other Intervention Names

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Huatuo Brand Type SDZ-II

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital of Fourth Military Military Medical University

Principal Investigators

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Lize Xiong, M.D.

Role: STUDY_CHAIR

Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University

Locations

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Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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Yang L, Yang J, Wang Q, Chen M, Lu Z, Chen S, Xiong L. Cardioprotective effects of electroacupuncture pretreatment on patients undergoing heart valve replacement surgery: a randomized controlled trial. Ann Thorac Surg. 2010 Mar;89(3):781-6. doi: 10.1016/j.athoracsur.2009.12.003.

Reference Type DERIVED
PMID: 20172127 (View on PubMed)

Other Identifiers

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XJ-20080808

Identifier Type: -

Identifier Source: org_study_id