Clinical trial NCT00732459: Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery
Official title: Clinical Trial of The Myocardial Protective Effects of Repeated Electroacupuncture Preconditioning in Heart Valve Replacement Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Valve Disease
Keywords: myocardial protection
cardiac surgery
heart valve replacement
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2008-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: late loss
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Anesthesiology of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Director of Department of Anasthesiology of Xijing Hospital, Fourth Military Medical University
name: Lize Xiong, M.D.
role: STUDY_CHAIR
References:
citation: 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.