Multimodal Investigation of Intracranial Clot Environment (MISO)

May 27, 2024 updated by: University Hospital, Montpellier
Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke

Description

Inclusion criteria:

  1. Over 18 years of age,
  2. Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score >2)
  3. Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner).

Exclusion criteria:

  1. Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study.
  2. Major patients under guardianship or curatorship or patients deprived of liberty

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute ischemic stroke
Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke
Other: Analysis of the clot
Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metalloproteinase 9 quantification
Time Frame: 60 months
60 months
Metalloproteinase 2 quantification
Time Frame: 60 months
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines levels
Time Frame: 60 months
Proteomic analysis of cytokines IL-1β, TNF-α, IL-6
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Genomic Institute of Montpellier

Investigators

  • Principal Investigator: Vincent COSTALAT, MD PhD, Montpellier University Hospital

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)

March 14, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL18_0236

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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