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Outcome of Patients With Congenital Heart Disease (OUTCARDIOP)

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Outcome research
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Congenital Heart Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All children and adults with congenital heart disease

Exclusion Criteria:

  • Parental or patient refusal
  • Patients presenting for cardiac interventions

Sites / Locations

  • Cliniques Universitaires Saint Luc

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Congenital Heart Disease

Arm Description

Undergoing evaluation at 30 days

Outcomes

Primary Outcome Measures

The prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a single-centre tertiary hospital
To analyze the exact number of children and adults with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital

Secondary Outcome Measures

To analyze morbidity after non-cardiac interventions in patients with congenital heart disease
Morbidity outcome after non-cardiac interventions
To analyze mortality after non-cardiac interventions in patients with congenital heart disease
Mortality outcome after non-cardiac interventions

Full Information

First Posted
April 10, 2019
Last Updated
October 21, 2020
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03913520
Brief Title
Outcome of Patients With Congenital Heart Disease
Acronym
OUTCARDIOP
Official Title
Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 28, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Congenital Heart Disease
Arm Type
Other
Arm Description
Undergoing evaluation at 30 days
Intervention Type
Other
Intervention Name(s)
Outcome research
Intervention Description
patients will undergo an evaluation of their outcome at 30 days postoperatively
Primary Outcome Measure Information:
Title
The prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a single-centre tertiary hospital
Description
To analyze the exact number of children and adults with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
To analyze morbidity after non-cardiac interventions in patients with congenital heart disease
Description
Morbidity outcome after non-cardiac interventions
Time Frame
30 days
Title
To analyze mortality after non-cardiac interventions in patients with congenital heart disease
Description
Mortality outcome after non-cardiac interventions
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All children and adults with congenital heart disease Exclusion Criteria: Parental or patient refusal Patients presenting for cardiac interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona MOMENI, MD,PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outcome of Patients With Congenital Heart Disease

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