Ischemic StrokeMATISSENCT05658835
Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction
An observational study of Ischemic Stroke, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Thrombi and blood analyses
- How many people
- 311 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Feb 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from ischemic stroke
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU Martinique
Fort-de-France, 97261
Quentin Bourgeois
Cristina Iosif
- Recruiting
Stroke Center
Marseille
Emilie DOCHE, emilie.doche@ap-hm.fr
- Recruiting
CHU Guadeloupe
Pointe à Pitre, 97139
Anne Landais
- Recruiting
CHU La Réunion
Saint-Pierre
Mirebeau Gabriel
Julien Dufour
About this study
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
- Being tested
- Thrombi and blood analyses
- Keywords
- ischemic stroke, thrombi, metabolites
- Medical subject headings
- Ischemic Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombi and blood analysesOther
Thrombi and blood will be collected during thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Patient suffering from ischemic stroke | Not described Receives: Other: Thrombi and blood analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months after the cerebral infarction
Secondary outcomes (11)
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)
Measured: 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)
Measured: 3 months after the cerebral infarction
Severe intracranial hemorrhage
Heildeberg classification (0 to 3d, 3d meaning subdural hemorrhage)
Measured: 3 months after the cerebral infarction
Recovery of autonomy in walking
Parker score (0 to 9, 9 meaning better outcome)
Measured: 3 months after the cerebral infarction
Recovery of autonomy in walking
Parker score (0 to 9, 9 meaning better outcome)
Measured: 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)
Measured: 24 hours after recanalization treatment
Use of thrombolytic therapy in the acute phase
Quantification of thrombolytic therapy
Measured: 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)
Measured: Right after the thrombectomy
Positive infarct growth after successful recanalization
Quantification of infarctus volume by MRI
Measured: Between 24 and 48h after the thrombectomy
Death
Death of the patient
Measured: 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)
Measured: 96 hours before cerebral infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start8 Feb 2023
- Primary completion7 Nov 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Crémieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658835
- Sponsor's protocol ID
- RCAPHM22_0231
- Other IDs
- ID-RCB
- Acronym
- MATISSE
- Status last verified
- Jul 2023
- First submitted
- 8 Dec 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction
- ClinicalTrials.gov ID
- NCT05658835
- Acronym / sponsor ID
- MATISSE / RCAPHM22_0231
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, thrombi, metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 311 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 7 Nov 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient suffering from ischemic stroke | – | Other: Thrombi and blood analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from ischemic stroke
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrombi and blood analysesThrombi and blood will be collected during thrombectomy | Other | Patient suffering from ischemic stroke |
Primary outcome
Determination and validation of molecular signatures, obtained by LC-MS analysis of cerebral thrombi, predictive of the excellent clinical prognosis
Time frame: 3 months after the cerebral infarction
Rankin score (0 to 6, 6 meaning worse outcome)
11 secondary outcomes
Determination and validation of molecular signatures, obtained by LC-MS analysis
Time frame: 7 days after the cerebral infarction
Determination and validation of molecular signatures, obtained by LC-MS analysis
Time frame: 3 months after the cerebral infarction
Severe intracranial hemorrhage
Time frame: 3 months after the cerebral infarction
Recovery of autonomy in walking
Time frame: 3 months after the cerebral infarction
Recovery of autonomy in walking
Time frame: 7 days after the cerebral infarction
Early Neurological Deterioration
Time frame: 24 hours after recanalization treatment
Use of thrombolytic therapy in the acute phase
Time frame: Before thrombectomy
Determination of molecular signatures predictive on successful recanalization after mechanical thrombectomy
Time frame: Right after the thrombectomy
Positive infarct growth after successful recanalization
Time frame: Between 24 and 48h after the thrombectomy
Death
Time frame: 3 months after cerebral infarction
Patient exposure to peak outdoor air pollution
Time frame: 96 hours before cerebral infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Crémieux study director
AP-HM
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Assistance Publique Hopitaux De Marseille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Doche (04 91 38 78 65 ext. 33, emilie.doche@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination and validation of molecular signatures, obtained by LC-MS analysis of cerebral thrombi, predictive of the excellent clinical prognosis (time frame: 3 months after the cerebral infarction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.