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

Ischemic Stroke Clinical Trial

— MATISSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05658835
• Other study ID #: RCAPHM22_0231
• Secondary ID: ID-RCB
• Status: Recruiting
• Start date: February 8, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Emilie Doche
• Phone: 04 91 38 78 65
• Email: emilie.doche[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 311
• Est. completion date: February 28, 2025
• Est. primary completion date: November 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction
• Intracranial Thrombosis
• Ischemic Stroke
• Thrombosis

Intervention

Other:
• Thrombi and blood analyses
Thrombi and blood will be collected during thrombectomy

Locations

Country	Name	City	State
France	CHU Martinique	Fort-de-France
France	Stroke Center	Marseille
France	CHU Guadeloupe	Pointe-à-Pitre
France	CHU La Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Severe intracranial hemorrhage	Heildeberg classification (0 to 3d, 3d meaning subdural hemorrhage)	3 months after the cerebral infarction
Secondary	Recovery of autonomy in walking	Parker score (0 to 9, 9 meaning better outcome)	3 months after the cerebral infarction
Secondary	Recovery of autonomy in walking	Parker score (0 to 9, 9 meaning better outcome)	7 days after the cerebral infarction
Secondary	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
Secondary	Use of thrombolytic therapy in the acute phase	Quantification of thrombolytic therapy	Before thrombectomy
Secondary	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
Secondary	Positive infarct growth after successful recanalization	Quantification of infarctus volume by MRI	Between 24 and 48h after the thrombectomy
Secondary	Death	Death of the patient	3 months after cerebral infarction
Secondary	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