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Outcome of Patients With Congenital Heart Disease (OUTCARDIOP)

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ClinicalTrials.gov Identifier: NCT03913520
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date May 9, 2019
Actual Study Start Date  ICMJE April 28, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
The prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a single-centre tertiary hospital [ Time Frame: Intraoperative ]
To analyze the exact number of children and adults with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03913520 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • To analyze morbidity after non-cardiac interventions in patients with congenital heart disease [ Time Frame: 30 days ]
    Morbidity outcome after non-cardiac interventions
  • To analyze mortality after non-cardiac interventions in patients with congenital heart disease [ Time Frame: 30 days ]
    Mortality outcome after non-cardiac interventions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome of Patients With Congenital Heart Disease
Official Title  ICMJE Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions
Brief Summary Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.
Detailed Description

Previous studies have shown that children and adults presenting with congenital heart disease are at increased risk of morbidity and mortality after non-cardiac interventions. This risk depends on the type of pathology, the age of the patient and the experience of the physicians in charge of these patients.

We sought to determine the prevalence of children and adults with congenital heart disease presenting for non-cardiac interventions and to investigate their outcome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE Other: Outcome research
patients will undergo an evaluation of their outcome at 30 days postoperatively
Study Arms  ICMJE Congenital Heart Disease
Undergoing evaluation at 30 days
Intervention: Other: Outcome research
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All children and adults with congenital heart disease

Exclusion Criteria:

  • Parental or patient refusal
  • Patients presenting for cardiac interventions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mona MOMENI, MD, PhD +3227647029 mona.momeni@uclouvain.be
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913520
Other Study ID Numbers  ICMJE 2019/12FEV/072
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mona MOMENI, MD,PhD Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP