- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825679
Association Between the Composition of the Bacterial Flora of Thrombi and the Etiological Origin of Cerebral Infarction Treated With Thrombectomy (Bacillus)
November 24, 2021 updated by: Centre Hospitalier Universitaire Dijon
Association Between the Composition of the Bacterial Flora of Thrombi and the Etiological Origin of Cerebral Infarctions Treated With Thrombectomy
Cerebral infarction is a major health problem.
The two most common causes are atherosclerosis (30 to 35%) and cardio-embolic origin (35 to 40%).
However, in 25% of cases the cause is undetermined, known as cryptogenic stroke or stroke of undetermined origin.
Paroxysmal Atrial Fibrillation appears to cause a significant proportion of these cryptogenic cerebral infarctions.
One of the major challenges in the management of cerebral infarctions is the prevention of recurrence.
If the cause is atheromatous, treatment is based on platelet antiaggregants and the correction of cardiovascular risk factors.
If the cause is atrial fibrillation, the treatment of choice is anticoagulation therapy.
Cryptogenic strokes are managed with antiplatelet therapy.
In past studies, the thrombi responsible for cerebral infarctions have been analyzed anatomopathologically to see if the composition of the thrombi could help identify the cause of the cerebral infarction.
These studies have proved to be contradictory.
The composition of the bacterial flora of cerebral infarct thrombi has not yet been studied, apart from some limited data on septic emboli.
In myocardial infarction, the cause of which is almost exclusively atheromatous, bacteria of the periodontal flora have been detected in thrombi of ST-segment elevation infarctions.
The causes of cerebral infarction are multiple.
The hypotheses explored in this study are that there are differences in the composition of the bacterial flora of the thrombus depending on whether the cause is atheromatous or cardio-embolic and that the study of the composition of the thrombus could be used to identify the cardio-embolic cause in patients with cryptogenic cerebral infarction.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dijon, France, 21079
- Centre Hospitalier Universitaire
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient hospitalized at the Neurovascular Intensive Care Unit at the Dijon University Hospital
Description
Inclusion Criteria:
- Person who has given oral consent (or a close relative or legal representative if the patient is unable to give consent)
- Patient with a symptomatic cerebral infarction defined according to WHO criteria, who has had a mechanical thrombectomy and was hospitalized at the Neurovascular Intensive Care Unit of the Dijon University Hospital.
- 18 years or older
Exclusion Criteria:
- Person not affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person under court order
- Pregnant or breastfeeding
- Patient who refuses to participate in the study
- Patient (or family member) not reachable by telephone during follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin
Time Frame: Through study completion, an average of 2 years
|
Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.
|
Through study completion, an average of 2 years
|
|
Bacterial composition of cardio-embolic thrombi
Time Frame: Through study completion, an average of 2 years
|
Comparison of the bacterial composition of thrombi from cerebral infarctions of atheromatous origin and thrombi of cardio-embolic origin.
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2019
Primary Completion (Actual)
October 4, 2019
Study Completion (Actual)
January 4, 2020
Study Registration Dates
First Submitted
January 25, 2019
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEJOT 2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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