Predisposition to Infectious Endocarditis
Gender Study on Predisposition to Infectious Endocarditis
2 other identifiers
observational
450
1 country
1
Brief Summary
To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJune 14, 2019
June 1, 2019
3 years
June 6, 2019
June 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Evolution of sex ratio as a function of age and underlying pathologies (comorbidities and valvulopathies)
36 months
Secondary Outcomes (1)
transcriptional profile by microarray
36 months
Study Arms (1)
sex ratio evaluation
Valvular surgery is performed in 30-40% of cases. The Cardiology and Cardiac Surgery De la Timone services 1000 patients as part of their valvulopathy and 450 benefit from cardiac surgery. On the other hand, transcriptomic analysis by microarray will only be done on 40 patients because the analysis costs 150 € / patients.
Interventions
Histological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found.
Eligibility Criteria
Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
You may qualify if:
- Patient with infectious endocarditis
- Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
- Major patient
- Patient informed of the study and having expressed no opposition to participate in the study.
- Patient affiliated to a social security scheme.
You may not qualify if:
- Minor patient
- Pregnant or nursing patient.
- Patient deprived of liberty or under judicial decision.
- Major patient under tutorship or curatorship.
- Patient not agreeing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratoires d'immunologie et d'infectiologie
Marseille, Cedex 5, 13354, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean-Olivier ARNAUD
AP HM
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 7, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2022
Study Completion
July 1, 2022
Last Updated
June 14, 2019
Record last verified: 2019-06