Outcome of Patients With Congenital Heart Disease

NCT03913520 | Completed DMC

• 1 other identifier: 2019/12FEV/072
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Intraoperative

Secondary Outcomes (2)

• To analyze morbidity after non-cardiac interventions in patients with congenital heart disease

  30 days

• To analyze mortality after non-cardiac interventions in patients with congenital heart disease

  30 days

Study Arms (1)

Congenital Heart Disease

OTHER

Undergoing evaluation at 30 days

Other: Outcome research

Interventions

Outcome research OTHER

patients will undergo an evaluation of their outcome at 30 days postoperatively

Congenital Heart Disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All children and adults with congenital heart disease

You may not qualify if:

• Parental or patient refusal
• Patients presenting for cardiac interventions

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Outcome Assessment, Health Care

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Mona MOMENI, MD,PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: April 28, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)