Postoperative Troponin in Children With Congenital Heart... | NCT01616394

Studies
Postoperative Troponin in Children With Congenital Heart Disease

NCT01616394

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Feb 8, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Momeni, MD,PhD; Chef de Clinique Adjointe, Department of Anesthesiology, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPrincipal Investigator

Lead Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to evaluate the value of postoperative troponin in the prediction of mid term and long term mortality and morbidity in children with congenital heart disease undergoing cardiac surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Label	Type	Description	Intervention Names
children with congenital heart disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality		3 months

Secondary Outcomes

Measure	Description	Time Frame
morbidity and mortality and length of stay in the PICU and in the hospital		in hospital; 3 months; 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all children with congenital heart disease between 0-10 years admitted for elective or emergency corrective or palliative cardiac surgery

Exclusion Criteria:

parental refusal
children older than 10 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

children with congenital heart disease admitted for surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mona MOMENI, MD	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Universitaires saint Luc		Brussels		1200	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27431598	Derived	Momeni M, Poncelet A, Rubay J, Matta A, Veevaete L, Detaille T, Houtekie L, Clement de Clety S, Derycke E, Moniotte S, Sluysmans T, Veyckemans F. Does Postoperative Cardiac Troponin-I Have Any Prognostic Value in Predicting Midterm Mortality After Congenital Cardiac Surgery? J Cardiothorac Vasc Anesth. 2017 Feb;31(1):122-127. doi: 10.1053/j.jvca.2016.02.018. Epub 2016 Feb 23.

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities