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OpenTrials
Active, Not Recruiting

NCT Number: NCT06777615

Electronic Archive of Patients With Congenital Heart Disease and Diagnosis of Infective Endocarditis

The objective of the study is to create an electronic archive in which to census all newly diagnosed or already diagnosed cases of infective endocarditis and congenital heart disease after 01 January 2022 at the IRCCS AOU Bologna Pediatric and Developmental Age Cardiology Center so that be able to describe the clinical and echocardiographic features in patients with congenital heart disease and infective endocarditis in this population in order to be able to define new diagnostic/epidemiological hypotheses and the identification of predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital heart disease and EI.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

It is well known in the literature that in patients with congenital heart disease, the risk of developing infective endocarditis (IE) is higher than in the general population with significant variation according to the underlying heart disease.It is essential to identify patients with congenital heart disease at higher risk of developing infective endocarditis and its related complications.Therefore, it is necessary to study the case history of patients with infective endocarditis and heart disease congenital heart disease (analysis of clinical-instrumental data, medical history, comorbidities, the cardiovascular adverse events and population mortality). The objective of the study is to create an electronic archive in which to census all newly diagnosed or already diagnosed cases of infective endocarditis and congenital heart disease after 01 January 2022 at the IRCCS AOU Bologna Pediatric and Developmental Age Cardiology Center so that be able to describe the clinical and echocardiographic features in patients with congenital heart disease and infective endocarditis in this population in order to be able to define new diagnostic/epidemiological hypotheses and the identification of predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital heart disease and EI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with congenital heart disease and established diagnosis of infective endocarditis referred to the UO Cardiology and Pediatric Cardiac Surgery Dell'IRCCS AOU of Bologna from 01/01/2000 until to approval (retrospective phase) and from approval until at least 31/12/2027 (prospective phase)
  • Obtaining informed consent for participation in the study

Exclusion criteria

  • no one

Treatment and study plan

Primary outcomes

  1. To identify predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital hea

    Time frame: Through study completion, an average of 5 years

    mortality, and related cause, re-hospitalization following diagnosis of EI (infective endocarditis).

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: IE-CHD

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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