Multimodal Investigation of Intracranial Clot Environment (MISO)

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: Not yet recruiting
• Conditions: Brain Ischemia; Acute Ichemic Stroke
• Intervention / Treatment: Other: Analysis of the clot

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 (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Cyril DARGAZANLI, MD MSc; Phone Number: +33 467337532; Email: c-dargazanli@chu-montpellier.fr
• Study Contact Backup: Name: Vincent COSTALAT, MD PhD; Phone Number: +33 467337532; Email: v-costalat@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	60 months
Metalloproteinase 2 quantification	60 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Genomic Institute of Montpellier
• Investigators: Principal Investigator: Vincent COSTALAT, MD PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): 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): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Thrombus; Ischemia; Blood Brain Barrier; Interventional Neuroradiology
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Ischemia
• 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