Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction (MATISSE)

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

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: Thrombi and blood analyses

• Study Type: Observational
• Enrollment (Estimated): 311

Contacts and Locations

• Study Contact: Name: Emilie Doche; Phone Number: 33 04 91 38 78 65; Email: emilie.doche@ap-hm.fr

Study Locations

• France
  • Fort-de-France, France, 97261
    • Recruiting
    • CHU Martinique
    • Contact: Quentin Bourgeois
    • Sub-Investigator: Cristina Iosif
  • Marseille, France
    • Recruiting
    • Stroke Center
    • Contact: Emilie DOCHE; Email: emilie.doche@ap-hm.fr
  • Pointe-à-Pitre, France, 97139
    • Recruiting
    • CHU Guadeloupe
    • Contact: Anne Landais
  • Saint-Pierre, France
    • Recruiting
    • CHU La Réunion
    • Contact: Mirebeau Gabriel
    • Sub-Investigator: Julien Dufour
    • Sub-Investigator: Marc Bindtner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients suffering from ischemic stroke

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient suffering from ischemic stroke	Other: Thrombi and blood analyses; Thrombi and blood will be collected during thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
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)	3 months after the cerebral infarction
Severe intracranial hemorrhage	Heildeberg classification (0 to 3d, 3d meaning subdural hemorrhage)	3 months after the cerebral infarction
Recovery of autonomy in walking	Parker score (0 to 9, 9 meaning better outcome)	3 months after the cerebral infarction
Recovery of autonomy in walking	Parker score (0 to 9, 9 meaning better outcome)	7 days after the cerebral infarction
Early Neurological Deterioration	Worsening of at least 4 points in the NIHSS (National Institutes of Health Stroke Scale) score (0 meaning better outcome, 0 to 42)	24 hours after recanalization treatment
Use of thrombolytic therapy in the acute phase	Quantification of thrombolytic therapy	Before thrombectomy
Determination of molecular signatures predictive on successful recanalization after mechanical thrombectomy	Score mTICI (modified Thrombolysis In Cerebral Infarction, 0 to 3, 0 meaning worst outcome)	Right after the thrombectomy
Positive infarct growth after successful recanalization	Quantification of infarctus volume by MRI	Between 24 and 48h after the thrombectomy
Death	Death of the patient	3 months after cerebral infarction
Patient exposure to peak outdoor air pollution	Quantification of peak outdoor air pollution (identification of the location of the patient and the polluants observed in the areas)	96 hours before cerebral infarction

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): November 7, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ischemic stroke; metabolites; thrombi
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Brain Ischemia; Stroke; Brain Infarction; Intracranial Embolism and Thrombosis; Thromboembolism; Infarction; Ischemic Stroke; Thrombosis; Cerebral Infarction; Intracranial Thrombosis
• Other Study ID Numbers: RCAPHM22_0231; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No