Myocardial Protection With Adenosine Preconditioning - Full Text View

Sponsored by:	Xijing Hospital
Information provided by:	Xijing Hospital
ClinicalTrials.gov Identifier:	NCT00881686

Purpose

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	Intervention	Phase
Heart Defects, Congenital Cardiac Surgical Procedures Myocardial Reperfusion Injury Adenosine	Drug: adenosine	Phase I Phase II

MedlinePlus related topics: Congenital Heart Defects Heart Surgery Surgery

Drug Information available for: Adenosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of Myocardial Protection in Pediatric Cardiac Surgery With Adenosine Preconditioning

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:

Outcome Measure: all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The time of ICU stay [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: No ]

Enrollment:	238
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
adenosine: Experimental Adenosine will be administered intravenously before surgery	Drug: adenosine 1.5mg/Kg adenosine will be administered intravenously before surgery

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

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881686

Locations

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

Sponsors and Collaborators

Xijing Hospital

Investigators

Principal Investigator:

Zhenxiao Jin, MD

Xijing Hospital

More Information

No publications provided

Responsible Party:	Xijing Hospital ( Zhenxiao Jin )
Study ID Numbers:	xinzangwaike0002
Study First Received:	April 14, 2009
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00881686 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Xijing Hospital:

Ischemic Preconditioning, Myocardial
Adenosine

Study placed in the following topic categories:

Vasodilator Agents
Heart Diseases
Cardiovascular Abnormalities
Myocardial Ischemia
Vascular Diseases
Cardiovascular Agents
Ischemia
Cardiomyopathies
Myocardial Reperfusion Injury

Postoperative Complications
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Congenital Abnormalities
Heart Defects, Congenital
Adenosine
Reperfusion Injury

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Cardiovascular Abnormalities
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Cardiomyopathies
Pharmacologic Actions
Myocardial Reperfusion Injury
Pathologic Processes
Postoperative Complications

Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Analgesics
Congenital Abnormalities
Central Nervous System Agents
Heart Defects, Congenital
Adenosine
Reperfusion Injury

ClinicalTrials.gov processed this record on May 07, 2009