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

NCT05658835 | Unknown

• 2 other identifiers: RCAPHM22_0231ID-RCB
• Study Type: observational
• Target: 311
• Locations: 1 country
• Sites: 4

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

Conditions

Ischemic Stroke

Keywords

ischemic stroke; thrombi; metabolites

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• Determination and validation of molecular signatures, obtained by LC-MS analysis

  7 days after the cerebral infarction

• Determination and validation of molecular signatures, obtained by LC-MS analysis

  3 months after the cerebral infarction

• Severe intracranial hemorrhage

  3 months after the cerebral infarction

• Recovery of autonomy in walking

  3 months after the cerebral infarction

• Recovery of autonomy in walking

  7 days after the cerebral infarction

Study Arms (1)

Patient suffering from ischemic stroke

Other: Thrombi and blood analyses

Interventions

Thrombi and blood analyses OTHER

Thrombi and blood will be collected during thrombectomy

Patient suffering from ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from ischemic stroke

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (4)

CHU Martinique

Fort-de-France, 97261, France

RECRUITING

Stroke Center

Marseille, France

RECRUITING

CHU Guadeloupe

Pointe à Pitre, 97139, France

RECRUITING

CHU La Réunion

Saint-Pierre, France

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Thrombosis

Interventions

Blood Coagulation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• François Crémieux

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Emilie Doche

CONTACT

04 91 38 78 65; emilie.doche@ap-hm.fr

Study Design

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

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 21, 2022
• Study Start: February 8, 2023
• Primary Completion: November 7, 2024
• Study Completion: February 28, 2025
• Last Updated: January 31, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)