Interest of Molecular Analysis of Cerebral Thrombi in Det... | NCT05658835

Studies
Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction

NCT05658835

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

Jan 31, 2024Actual

Enrollment

311Estimated

Phase

Not provided

Conditions

Ischemic Stroke

Interventions

Thrombi and blood analyses

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

ID	Type	Description	Link
ID-RCB	Other Identifier	2022-A01860-43

Status Module

Record Verification Date

Jul 2023

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

Feb 8, 2023Actual

Primary Completion Date

Nov 7, 2024Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Dec 8, 2022

First Submission Date that Met QC Criteria

Dec 17, 2022

First Posted Date

Dec 21, 2022Actual

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

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

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

The MATISSE (Molecular Analysis of Thrombus for Ischemic Stroke prognosis and Etiology) project evaluates the hypothesis that the molecular composition of cerebral thrombus in metabolites, lipids, and proteins conditions the clinical prognosis at 3 months of the infarction and informs on its etiological subtype

Detailed Description

Not provided

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

311Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient suffering from ischemic stroke			Other: Thrombi and blood analyses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrombi and blood analyses	Other	Thrombi and blood will be collected during thrombectomy	Patient suffering from ischemic stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination and validation of molecular signatures, obtained by LC-MS analysis of cerebral thrombi, predictive of the excellent clinical prognosis	Rankin score (0 to 6, 6 meaning worse outcome)	3 months after the cerebral infarction

Secondary Outcomes

Measure	Description	Time Frame
Determination and validation of molecular signatures, obtained by LC-MS analysis	ASCOD (atherosclerosis, small vessel disease (SVD), cardioembolism, other and dissection) description (0 to 9, 9 meaning insufficient assessment to determine the presence or absence of the disease)	7 days after the cerebral infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female 18 years of age or older;
Patient with a cerebral infarction documented by brain imaging who received endovascular treatment by mechanical thrombectomy;
Patient for whom it was possible to collect cerebral thrombus for LC-MS analysis during mechanical thrombectomy:
Patient who was informed of the study and formulated a non-opposition to participation. If not, patient for whom a relative was informed and formulated a non-opposition.

Exclusion Criteria:

Patient with a cerebral infarction documented by cerebral imaging, having benefited from an endovascular treatment with mechanical thrombectomy that did not allow the extraction of a cerebral thrombus.
Protected persons (articles L1121-5, L1121-6 and L121-8 of the Public Health Code): pregnant or breast-feeding women, persons deprived of liberty, under guardianship or curatorship

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from ischemic stroke

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilie Doche	Contact	04 91 38 78 65	33	emilie.doche@ap-hm.fr

Overall Officials

Name	Affiliation	Role
François Crémieux	AP-HM	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Martinique	Recruiting	Fort-de-France		97261	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
D000083242	Ischemic Stroke
D013927	Thrombosis

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001777	Blood Coagulation

Ancestor Terms

ID	Term
D006487	Hemostasis
D001790	Blood Physiological Phenomena
D002943	Circulatory and Respiratory Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided