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RecruitingNCT04421326MISOUpdated May 29, 2024

Multimodal Investigation of Intracranial Clot Environment

An observational study in Acute Ichemic Stroke and Brain Ischemia, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

Read the 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.

02

Conditions studied

  • Acute Ichemic Stroke
  • Brain Ischemia

Keywords

  • Stroke
  • Blood Brain Barrier
  • Ischemia
  • Thrombus
  • Interventional Neuroradiology
03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with acute ischemic stroke

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

    Other: Analysis of the clot

Interventions

  • OtherAnalysis of the clot

    Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy

05

What researchers measure

Primary outcomes

  1. Metalloproteinase 9 quantification

    Time frame: 60 months

  2. Metalloproteinase 2 quantification

    Time frame: 60 months

Secondary outcomes

  1. Cytokines levels

    Proteomic analysis of cytokines IL-1β, TNF-α, IL-6

    Time frame: 60 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04421326
Lead sponsor
University Hospital, Montpellier
Collaborators
Genomic Institute of Montpellier
Responsible party
Sponsor
First posted
Jun 9, 2020
Start date
Mar 14, 2021
Primary completion
Jun 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
May 29, 2024

Study contacts

Cyril DARGAZANLI, MD MSc
Contact
c-dargazanli@chu-montpellier.fr
467337532 ext. +33
Vincent COSTALAT, MD PhD
Contact
v-costalat@chu-montpellier.fr
467337532 ext. +33
Vincent COSTALAT, MD PhD
principal investigator · Montpellier University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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