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

NCT06777615 | Active Not Recruiting

• 1 other identifier: IE-CHD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease (CHD); Infective Endocarditis (IE)

Outcome Measures

Primary Outcomes (1)

• 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).

  Through study completion, an average of 5 years

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• no one

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Endocarditis

Condition Hierarchy (Ancestors)

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

Study Officials

• Ylenia Bartolacelli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 16, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)