NCT01656941|Completed
Genetic Determinants of Congenital Heart Disease Outcomes
GECHO
The GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes
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GECHO
The GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes
Sponsor study identifier
observational
250
2 countries
5
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 16, 2017
Actual (reported)Study Completion
March 16, 2017
Actual (reported)The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery. The goals will be to determine 1) if the oxidative stress pathway is an important one for therapeutic intervention in neonates with severe congenital heart defects and 2) if variants in the oxidative response pathway can be used to identify patients at increased risk for adverse outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 16, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 19, 2012
Actual (reported)August 3, 2012
Actual (reported)March 16, 2017
Actual (reported)March 16, 2017
Actual (reported)Contribution of genetic variation in oxidative stress management to differences in short term outcomes after repair for severe cardiac disease in the neonatal period
Genotyping will be performed on 10 variants in the oxidative stress response pathway and we will combine risk genotypes in order to evaluate the cumulative effect of both detrimental and beneficial alleles on post-operative outcomes. Composite short term outcome measure includes: ICU length of stay (days) Time to initial extubation (hours) Cardiac arrest or ECMO support (Y/N) Delayed sternal closure (Y/N) Serious adverse event (Y/N) Greater than 1 serious adverse event (Y/N)
Duration of initial perioperative hospitalization (~2-4 weeks)
Contribution of genetic variation in oxidative stress management to differences in interstage mortality and pre-Stage II cardiovascular function in patients with single ventricle cardiac disease
Interval from hospital discharge following stage I surgical palliation until hospital admission for stage II surgical palliation (~4-6 months of age)
Neonates with d-transposition of the great arteries (dTGA) undergoing the arterial switch operation with cardiopulmonary bypass
Neonates with single ventricle cardiac disease (SVCD) undergoing stage I surgical palliation (Norwood) with cardiopulmonary bypass
Neonates with d-transposition of the great arteries undergoing the arterial switch procedure and neonates with single ventricle cardiac disease undergoing stage I surgical palliation at the University of Michigan or other collaborating institutions.
Emory University
Atlanta, Georgia, 30322, United States
C.S. Mott Children's Hospital, University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
The Royal Children's Hospial Melbourne
Melbourne, Victoria, 3052, Australia
Whole blood samples will be frozen and stored until DNA can be isolated. Eventually, isolated DNA samples will be frozen and stored in a biorepository.
Nicole S Wilder, MD
University of Michigan
Mark W Russell, MD
University of Michigan
250 participants (actual enrollment reported by the registry).
First Submitted
July 19, 2012
First Posted
August 3, 2012
Study Start
March 2011
Date type not reportedThis date has not been verified as actual or estimated.
Prenatal Effects of Congenital Heart Disease (CHD) on Neurodevelopmental Outcome
Contact the study team to confirm eligibility.
Primary Completion
March 16, 2017
Actual (reported)Study Completion
March 16, 2017
Actual (reported)Last Updated
August 10, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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