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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • Dijon, France, 21079
        • Centre Hospitalier Universitaire

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire Dijon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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