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Myocardial Protection With Adenosine Preconditioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881686
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
Information provided by:
Xijing Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Defects, Congenital Cardiac Surgical Procedures Myocardial Reperfusion Injury Adenosine Drug: adenosine Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning
Study Start Date : June 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: adenosine
Adenosine will be administered intravenously before surgery
Drug: adenosine
1.5mg/Kg adenosine will be administered intravenously before surgery

Primary Outcome Measures :
  1. Outcome Measure: all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Secondary Outcome Measures :
  1. The time of ICU stay [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881686

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China, Shannxi
Institute of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shannxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
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Principal Investigator: Zhenxiao Jin, MD Xijing Hospital

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Responsible Party: Zhenxiao Jin, Xijing Hospital Identifier: NCT00881686    
Other Study ID Numbers: xinzangwaike0002
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: March 2009
Keywords provided by Xijing Hospital:
Ischemic Preconditioning, Myocardial
Additional relevant MeSH terms:
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Reperfusion Injury
Heart Defects, Congenital
Myocardial Reperfusion Injury
Congenital Abnormalities
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Cardiovascular Abnormalities
Heart Diseases
Myocardial Ischemia
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action