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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

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 7 months later.
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

In context

Brain Ischemia

217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.

This study's planned enrollment of 200 is close to the median of 203 across 72 observational studies indexed under Brain Ischemia.

Browse Brain Ischemia studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2021 (actual). Primary completion is estimated for Jun 2025, 51 months after the start.

Of 34 non-industry observational studies under Brain Ischemia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 121. This study's planned 51 months is below that.

Counting every sponsor, half of 36 studies reached it within 72 months; a quarter within 36 and three quarters within 121.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2020
First posted
Jun 9, 2020
StartActual
Mar 14, 2021
Primary completionEst.
Jun 2025
CompletionEst.
Oct 2025
Last update
May 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04421326
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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