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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

Tracking Information
First Submitted Date July 6, 2017
First Posted Date July 11, 2017
Last Update Posted Date September 13, 2018
Actual Study Start Date February 27, 2017
Estimated Primary Completion Date February 25, 2032   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2017)
Analysis of hospital mortality and long-term overall mortality. [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Prognosis of Infectious Endocarditis (EPEI)
Official Title Study of the Prognosis of Infectious Endocarditis (EPEI): Prospective and Retrospective Follow-up of a Cohort of Patients Hospitalized for Infectious Endocarditis
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients with certain infectious endocarditis according to Duke's criteria
Condition Endocarditis Infective
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 6, 2017)
645
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 25, 2032
Estimated Primary Completion Date February 25, 2032   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christophe TRIBOUILLOY, PhD +33322455885 tribouilloy.christophe@chu-amiens.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03211975
Other Study ID Numbers RNI2016-30
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire, Amiens
Study Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire, Amiens
Verification Date September 2018