An observational study in Congenital Heart Disease (CHD) and Infective Endocarditis (IE), sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Active, not recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 30 is below the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To identify predictive factors of adverse outcome (death, re-intervention, re-hospitalization) in patients with congenital hea
mortality, and related cause, re-hospitalization following diagnosis of EI (infective endocarditis).
Time frame: Through study completion, an average of 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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