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RecruitingNCT05658835MATISSEUpdated Jan 31, 2024

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

An observational study in Ischemic Stroke, sponsored by Assistance Publique Hopitaux De Marseille. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
311
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Ischemic Stroke

Keywords

  • ischemic stroke
  • thrombi
  • metabolites
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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 311 is close to the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients suffering from ischemic stroke

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
311 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient suffering from ischemic stroke

    Other: Thrombi and blood analyses

Interventions

  • OtherThrombi and blood analyses

    Thrombi and blood will be collected during thrombectomy

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What researchers measure

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)

    Time frame: 3 months after the cerebral infarction

Secondary outcomes

  1. 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)

    Time frame: 7 days after the cerebral infarction

  2. 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)

    Time frame: 3 months after the cerebral infarction

  3. Severe intracranial hemorrhage

    Heildeberg classification (0 to 3d, 3d meaning subdural hemorrhage)

    Time frame: 3 months after the cerebral infarction

  4. Recovery of autonomy in walking

    Parker score (0 to 9, 9 meaning better outcome)

    Time frame: 3 months after the cerebral infarction

  5. Recovery of autonomy in walking

    Parker score (0 to 9, 9 meaning better outcome)

    Time frame: 7 days after the cerebral infarction

  6. 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)

    Time frame: 24 hours after recanalization treatment

  7. Use of thrombolytic therapy in the acute phase

    Quantification of thrombolytic therapy

    Time frame: Before thrombectomy

  8. 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)

    Time frame: Right after the thrombectomy

  9. Positive infarct growth after successful recanalization

    Quantification of infarctus volume by MRI

    Time frame: Between 24 and 48h after the thrombectomy

  10. Death

    Death of the patient

    Time frame: 3 months after cerebral infarction

  11. 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)

    Time frame: 96 hours before cerebral infarction

07

Study locations

4 of 4 sites recruiting
  • CHU Martinique
    Fort-de-France, 97261, France
    • Quentin Bourgeois · Contact
    • Cristina Iosif · Sub investigator
    Recruiting
  • Stroke Center
    Marseille, France
    Recruiting
  • CHU Guadeloupe
    Pointe-à-Pitre, 97139, France
    • Anne Landais · Contact
    Recruiting
  • CHU La Réunion
    Saint-Pierre, France
    • Mirebeau Gabriel · Contact
    • Julien Dufour · Sub investigator
    • Marc Bindtner · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05658835
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Dec 21, 2022
Start date
Feb 8, 2023
Primary completion
Nov 7, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Jan 31, 2024

Study contacts

Emilie Doche
Contact
emilie.doche@ap-hm.fr
04 91 38 78 65 ext. 33
François Crémieux
study director · AP-HM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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