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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

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Other: Outcome research Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Postoperative Outcome of Patients With Congenital Heart Disease Presenting for Non-cardiac Interventions
Actual Study Start Date : April 28, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To analyze morbidity after non-cardiac interventions in patients with congenital heart disease [ Time Frame: 30 days ]
    Morbidity outcome after non-cardiac interventions

  2. To analyze mortality after non-cardiac interventions in patients with congenital heart disease [ Time Frame: 30 days ]
    Mortality outcome after non-cardiac interventions



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children and adults with congenital heart disease

Exclusion Criteria:

  • Parental or patient refusal
  • Patients presenting for cardiac interventions

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): NCT03913520


Contacts
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Contact: Mona MOMENI, MD, PhD +3227647029 mona.momeni@uclouvain.be

Locations
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Belgium
Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium, 1200
Contact: MONA MOMENI, MD, PhD         
Principal Investigator: MONA MOMENI, M.D.; PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Mona MOMENI, MD,PhD Cliniques universitaires Saint-Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03913520     History of Changes
Other Study ID Numbers: 2019/12FEV/072
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities