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Postoperative Troponin in Children With Congenital Heart Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01616394
First Posted: June 11, 2012
Last Update Posted: November 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Momeni, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  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 Momeni, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • mortality [ Time Frame: 3 months ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: February 8, 2012
First Posted: June 11, 2012
Last Update Posted: November 19, 2014
Last Verified: September 2013

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