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Study of the Prognosis of Infectious Endocarditis (EPEI) (EPEI)

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ClinicalTrials.gov Identifier: NCT03211975
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people.

The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.

The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data.

The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.

The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.


Condition or disease Intervention/treatment
Endocarditis Infective Other: To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses

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Study Type : Observational
Estimated Enrollment : 645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Prognosis of Infectious Endocarditis (EPEI): Prospective and Retrospective Follow-up of a Cohort of Patients Hospitalized for Infectious Endocarditis
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 25, 2032
Estimated Study Completion Date : February 25, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis


Intervention Details:
  • Other: To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses
    To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses


Primary Outcome Measures :
  1. Analysis of hospital mortality and long-term overall mortality. [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with certain infectious endocarditis according to Duke's criteria
Criteria

Inclusion Criteria:

  • all patients with certain infectious endocarditis according to Duke's criteria, confirmed by the presence of evocative images on the transthoracic and / or transesophageal ultrasound or by the data collected on the surgical specimens.

Exclusion Criteria:

  • Patients with an infection not meeting the Duke IE criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211975


Contacts
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Contact: Christophe TRIBOUILLOY, PhD +33322455885 tribouilloy.christophe@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Christophe TRIBOUILLOY, PhD    +33322455885    tribouilloy.christophe@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03211975     History of Changes
Other Study ID Numbers: RNI2016-30
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Streptococcal Infections
Communicable Diseases
Infection
Endocarditis
Endocarditis, Subacute Bacterial
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Gram-Positive Bacterial Infections
Cardiovascular Infections