Prognosis and Management of Infective Endocarditis Using the Clinical Data Warehouse From AP-HP

NCT06957119 | Completed

• 1 other identifier: APHP240997
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

"Infective endocarditis (IE) is a rare but severe condition with significant morbidity and mortality, with in-hospital mortality reaching 20% and 1-year mortality up to 40%. The epidemiological profile of IE has profoundly changed in recent years, both in terms of responsible microorganisms and affected populations, shifting from young adults with post-rheumatic valvulopathy to older populations with degenerative valve disease or prosthetic implants. Prophylaxis and management recommendations have also evolved, underscoring the importance of monitoring the evolution of IE profiles in France. Despite these changes, there is no standardized surveillance for IE in France, and existing studies often rely on data from specialized centers, introducing selection biases. Moreover, another important limitation when studying IE using medical-administrative basis, like the french nationwide claims database (SNDS), is the poor performances of administrative coding (ICD-10) in accurately identifying IE cases. The ""ENDO-EDS"" project aims to leverage the extensive data available in the APHP Clinical Data Warehouse (CDW) to study IE in a real-world, unbiased context. Indeed, the AP-HP clinical data warehouse, with 11 million patients, offers the opportunity to identify IE cases across a large population base and, due to the presence of both expert and non-expert IE hospitals, to describe the characteristics of the disease while reducing bias risks. In addition, AP-HP CDW contains medical reports and other documents emitted during patient' stays in hospital, thus enabling to overcome ICD-10 coding limitations, by utilizing a large-scale clinical data repository combined with advanced Natural Language Processing (NLP) algorithms. The anticipated benefits include improving knowledge of the epidemiological profile of IE, describing diagnostic and therapeutic management practices, and studying their impact on patient prognosis. These efforts aim to contribute to the improvement of IE diagnosis and management in France. The results will be published as scientific articles in open-access peer-reviewed journals. Additionally, the development and validation of algorithms based on automated language processing for identifying patients with IE within the AP-HP data warehouse could be shared to extend subsequent analyses to other French or even European health data warehouses."

Conditions

Endocarditis Infective

Keywords

infective endocarditis; Clinical Data Warehouse; NLP

Outcome Measures

Primary Outcomes (1)

• All-cause mortality defined 1 year after the date of IE diagnosis (T0 = Date of diagnostic echocardiography)

  1 year after the date of IE diagnosis (T0 = Date of diagnostic echocardiography)

Secondary Outcomes (19)

• Rate of patients who benefited from imaging procedures performed in the acute phase of IE (within 6 weeks following T0) identified from CCAM codes

  CCAM codes emitted within 6 weeks from T0 (date of IE determined through echocardiographic diagnosis)

• Rate of patients who underwent cardiac valve replacement surgery in the acute phase of IE

  Up to 6 week after IE diagnosis

• Clinical characteristics of patients with IE at diagnosis, extracted from administrative data (ICD-10 diagnoses, and CCAM medical procedures) and medical reports

  All data emitted in AP-HP hospitals prior to hospitalization for IE

• Microorganisms associated with IE, extracted from hospitalization medical reports using NLP

  Up to 6 week after IE diagnosis

• Iconographic characteristics of IE at diagnosis

  Up to 6 week after IE diagnosis

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AP-HP's Clinical Data Warehouse

The selection of patients will be carried out in 2 successive stages. A 1st stage of pre-selection of patients (Population 0) based on the following criteria: * Patients aged 18 or over hospitalized in MCO in an APHP department between 01/08/2017 and 31/12/2023; * Having benefited from a CCAM act of transthoracic and/or transesophageal echocardiography or * Presenting a textual mention of "endocarditis" or "IE" in one of the reports associated with the hospitalization or * Having an ICD-10 diagnostic code for infective endocarditis in the PMSI (I33, I38, T826, B376, I39) A second step will allow the identification of the study population (Population 1) of patients presenting with infective endocarditis (=gold standard) from a multimodal algorithm, notably based on automated language processing (TAL) algorithms applied to hospitalization, imaging, and pathology reports. Population 1 will be used to meet all of the study objectives with the exception of secondary objective no. 9 carried out using Population 0. Patients with no usable hospitalization reports will be excluded.

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Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat Claude Bernard Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Xavier Duval

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: May 4, 2025
• Study Start: August 1, 2017
• Primary Completion: December 1, 2023
• Study Completion: July 17, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

FR (1)