NCT04421326

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

March 14, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

4.2 years

First QC Date

May 28, 2020

Last Update Submit

May 27, 2024

Conditions

Keywords

StrokeBlood Brain BarrierIschemiaThrombusInterventional Neuroradiology

Outcome Measures

Primary Outcomes (2)

  • Metalloproteinase 9 quantification

    60 months

  • Metalloproteinase 2 quantification

    60 months

Secondary Outcomes (1)

  • Cytokines levels

    60 months

Study Arms (1)

Patients with acute ischemic stroke

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

Other: Analysis of the clot

Interventions

Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy

Patients with acute ischemic stroke

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Brain IschemiaStrokeIschemiaThrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and Thrombosis

Study Officials

  • Vincent COSTALAT, MD PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyril DARGAZANLI, MD MSc

CONTACT

Vincent COSTALAT, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 9, 2020

Study Start

March 14, 2021

Primary Completion

June 1, 2025

Study Completion

October 1, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations