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Myocardial Protection With Adenosine Preconditioning

Information source: Xijing Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Defects, Congenital; Cardiac Surgical Procedures; Myocardial Reperfusion Injury; Adenosine

Intervention: adenosine (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Xijing Hospital

Official(s) and/or principal investigator(s):
Zhenxiao Jin, MD, Principal Investigator, Affiliation: Xijing Hospital

Summary

Adenosine has been proved to be an important mediator of myocardial protection induced by ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can provide additional myocardial protection in the setting of pediatric open heart surgery with cardioplegia and cardiopulmonary bypass.

Clinical Details

Official title: Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Outcome Measure: all cause mortality

Secondary outcome: The time of ICU stay

Detailed description: Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many years. New progresses in myocardial protection in the settings of acute myocardial infarction treatment put forward the its clinical use to a broader field. But the safety and effectiveness of its use in myocardial protection in the setting of open heart surgery has not been investigated intensively. Our primary results suggested that adenosine preconditioning could decrease the release of myocardial serum markers, such as cTnI. This study will focus on the safety and effectiveness of adenosine in the field of pediatric myocardial protection during surgery repair of congenital heart defects with CPB and cardioplegia.

Eligibility

Minimum age: N/A. Maximum age: 24 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of congenital heart defects eligible for surgery treatment under

cardiopulmonary bypass and cardioplegia

- Body weight less than or equals to 10kg

Exclusion Criteria:

- Cardiac surgery is performed without cardiopulmonary or cardioplegia

- Body weight more than 10Kg

Locations and Contacts

Institute of Cardiovascular Surgery, Xijing Hospital, Xi'an, Shannxi 710032, China
Additional Information

Starting date: June 2008
Last updated: April 14, 2009

Page last updated: August 20, 2015

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