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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
The GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes
Secondary ID [1] 0 0
GECHO
Universal Trial Number (UTN)
Trial acronym
GECHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease 0 0
Hypoplastic Left Heart Syndrome 0 0
Hypoplastic Right Heart Syndrome 0 0
d-Transposition of the Great Arteries 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Contribution of genetic variation in oxidative stress management to differences in short term outcomes after repair for severe cardiac disease in the neonatal period
Timepoint [1] 0 0
Duration of initial perioperative hospitalization (~2-4 weeks)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Interval from hospital discharge following stage I surgical palliation until hospital admission for stage II surgical palliation (~4-6 months of age)

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
Minimum age
No limit
Maximum age
30 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known trisomy 13, 18, or 21
* Any major non-cardiac anomaly that precludes the patient from cardiac surgery

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/03/2017
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospial Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
South Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Michigan
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Children's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical University of South Carolina
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Emory University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Medical College of Wisconsin
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01656941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicole S Wilder, MD
Address 0 0
University of Michigan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01656941