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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01656941
Registration number
NCT01656941
Ethics application status
Date submitted
19/07/2012
Date registered
3/08/2012
Date last updated
10/08/2021
Titles & IDs
Public title
Genetic Determinants of Congenital Heart Disease Outcomes
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Scientific title
The GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes
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Secondary ID [1]
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GECHO
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Universal Trial Number (UTN)
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Trial acronym
GECHO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease
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Hypoplastic Left Heart Syndrome
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Hypoplastic Right Heart Syndrome
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d-Transposition of the Great Arteries
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
d-Transposition of the Great Arteries - Neonates with d-transposition of the great arteries (dTGA) undergoing the arterial switch operation with cardiopulmonary bypass
Single ventricle cardiac disease - Neonates with single ventricle cardiac disease (SVCD) undergoing stage I surgical palliation (Norwood) with cardiopulmonary bypass
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Contribution of genetic variation in oxidative stress management to differences in short term outcomes after repair for severe cardiac disease in the neonatal period
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Assessment method [1]
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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)
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Timepoint [1]
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Duration of initial perioperative hospitalization (~2-4 weeks)
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Secondary outcome [1]
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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
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Assessment method [1]
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Composite outcome
Growth parameters (height, weight, head circumference)
AV valve insufficiency (By echocardiogram and cardiac catheterization) , Ventricular function (ejection fraction by echocardiogram and by cardiac catheterization), Central venous pressure and ventricular end diastolic pressure (by catheterization), Interstage Death (Y/N).
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Timepoint [1]
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Interval from hospital discharge following stage I surgical palliation until hospital admission for stage II surgical palliation (~4-6 months of age)
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Eligibility
Key inclusion criteria
- d-transposition of the great arteries or single ventricle cardiac disease
- Less than or equal to 30 days of age
- Planned arterial switch operation or stage I surgical palliation (Norwood)with aortic
arch reconstruction
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Minimum age
No limit
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Maximum age
30
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known trisomy 13, 18, or 21
- Any major non-cardiac anomaly that precludes the patient from cardiac surgery
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/03/2017
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Sample size
Target
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Accrual to date
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Final
250
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Royal Children's Hospial Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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South Carolina
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Country [4]
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United States of America
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State/province [4]
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Wisconsin
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Michigan
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Royal Children's Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Medical University of South Carolina
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Emory University
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Medical College of Wisconsin
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01656941
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Nicole S Wilder, MD
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Address
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University of Michigan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01656941
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