Clinical trial NCT06777615: Electronic Archive of Patients With Congenital Heart Disease and Diagnosis of Infective Endocarditis
Official title: Electronic Archive of Patients With Congenital Heart Disease and Diagnosis of Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Congenital Heart Disease (CHD)
Infective Endocarditis (IE)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with bacterial endocarditis and congenital heart disease will be considered, referred to our center from 01 January 2000 and until at least 31 December 2027 going to include, according to a preliminary analysis, a cohort of about 30 patients for the two phases in the above period.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To identify predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital hea
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Ylenia Bartolacelli, MD
role: PRINCIPAL_INVESTIGATOR
References: