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Postoperative Troponin in Children With Congenital Heart Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Momeni, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01616394
First received: February 8, 2012
Last updated: November 18, 2014
Last verified: September 2013
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • morbidity and mortality and length of stay in the PICU and in the hospital [ Time Frame: in hospital; 3 months; 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: February 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
children with congenital heart disease

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

children with congenital heart disease admitted for surgery

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616394

Locations
Belgium
Cliniques Universitaires saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Mona MOMENI, MD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Momeni, MD,PhD; Chef de Clinique Adjointe, Department of Anesthesiology, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01616394     History of Changes
Other Study ID Numbers: 2011/07/DEC/460
Study First Received: February 8, 2012
Last Updated: November 18, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2014