Outcome of Patients With Congenital Heart Disease (OUTCARDIOP)

October 21, 2020 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All children and adults with congenital heart disease

Exclusion Criteria:

  • Parental or patient refusal
  • Patients presenting for cardiac interventions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Congenital Heart Disease
Undergoing evaluation at 30 days
Other: Outcome research
patients will undergo an evaluation of their outcome at 30 days postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyze morbidity after non-cardiac interventions in patients with congenital heart disease
Time Frame: 30 days
Morbidity outcome after non-cardiac interventions
30 days
To analyze mortality after non-cardiac interventions in patients with congenital heart disease
Time Frame: 30 days
Mortality outcome after non-cardiac interventions
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Mona Momeni, MD,PhD, Cliniques universitaires Saint-Luc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

April 10, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/12FEV/072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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