NCT01616394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

September 1, 2013

Enrollment Period

2.7 years

First QC Date

February 8, 2012

Last Update Submit

November 18, 2014

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • mortality

    3 months

Secondary Outcomes (1)

  • morbidity and mortality and length of stay in the PICU and in the hospital

    in hospital; 3 months; 6 months

Study Arms (1)

children with congenital heart disease

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children with congenital heart disease admitted for surgery

You may qualify if:

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

You may not qualify if:

  • parental refusal
  • children older than 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires saint Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 27431598DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mona MOMENI, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD; Chef de Clinique Adjointe, Department of Anesthesiology

Study Record Dates

First Submitted

February 8, 2012

First Posted

June 11, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 19, 2014

Record last verified: 2013-09

Locations

BE(1)