Multimodal Investigation of Intracranial Clot Environment | NCT04421326

Studies
Multimodal Investigation of Intracranial Clot Environment

NCT04421326

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

May 29, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Acute Ichemic Stroke
Brain Ischemia

Interventions

Analysis of the clot

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2021Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Oct 2025Estimated

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

Jun 4, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2024

Last Update Posted Date

May 29, 2024Actual

Name	Class
Genomic Institute of Montpellier	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute ischemic stroke		Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke	Other: Analysis of the clot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Analysis of the clot	Other	Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy	Patients with acute ischemic stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metalloproteinase 9 quantification		60 months
Metalloproteinase 2 quantification		60 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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).

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cyril DARGAZANLI, MD MSc	Contact	467337532	+33	c-dargazanli@chu-montpellier.fr
Vincent COSTALAT, MD PhD	Contact	467337532	+33	v-costalat@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
Vincent COSTALAT, MD PhD	Montpellier University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Montpellier	Recruiting	Montpellier			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002545	Brain Ischemia
D020521	Stroke
D007511	Ischemia
D013927	Thrombosis

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided