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NCT01656941 · ClinicalTrials.gov registry record
Genetic Determinants of Congenital Heart Disease Outcomes
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 250
- Enrollment target
NCT01656941: Completed study, sponsored by University of Michigan.
NCT01656941 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01656941 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-03-16 |
What the finished NCT01656941 record still lists
NCT01656941 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01656941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01656941 about?
NCT01656941 is a clinical study titled "Genetic Determinants of Congenital Heart Disease Outcomes". 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...
What is the current status of trial NCT01656941?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2011-03. Estimated completion is 2017-03-16.
Who is sponsoring clinical trial NCT01656941?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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