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
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