Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-29 @ 5:09 PM
Study NCT ID:
NCT05658835
Status:
UNKNOWN
Last Update Posted:
2024-01-31
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001777', 'term': 'Blood Coagulation'}], 'ancestors': [{'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 311}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-17', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination and validation of molecular signatures, obtained by LC-MS analysis of cerebral thrombi, predictive of the excellent clinical prognosis', 'timeFrame': '3 months after the cerebral infarction', 'description': 'Rankin score (0 to 6, 6 meaning worse outcome)'}], 'secondaryOutcomes': [{'measure': 'Determination and validation of molecular signatures, obtained by LC-MS analysis', 'timeFrame': '7 days after the cerebral infarction', 'description': '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)'}, {'measure': 'Determination and validation of molecular signatures, obtained by LC-MS analysis', 'timeFrame': '3 months after the cerebral infarction', 'description': '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)'}, {'measure': 'Severe intracranial hemorrhage', 'timeFrame': '3 months after the cerebral infarction', 'description': 'Heildeberg classification (0 to 3d, 3d meaning subdural hemorrhage)'}, {'measure': 'Recovery of autonomy in walking', 'timeFrame': '3 months after the cerebral infarction', 'description': 'Parker score (0 to 9, 9 meaning better outcome)'}, {'measure': 'Recovery of autonomy in walking', 'timeFrame': '7 days after the cerebral infarction', 'description': 'Parker score (0 to 9, 9 meaning better outcome)'}, {'measure': 'Early Neurological Deterioration', 'timeFrame': '24 hours after recanalization treatment', 'description': 'Worsening of at least 4 points in the NIHSS (National Institutes of Health Stroke Scale) score (0 meaning better outcome, 0 to 42)'}, {'measure': 'Use of thrombolytic therapy in the acute phase', 'timeFrame': 'Before thrombectomy', 'description': 'Quantification of thrombolytic therapy'}, {'measure': 'Determination of molecular signatures predictive on successful recanalization after mechanical thrombectomy', 'timeFrame': 'Right after the thrombectomy', 'description': 'Score mTICI (modified Thrombolysis In Cerebral Infarction, 0 to 3, 0 meaning worst outcome)'}, {'measure': 'Positive infarct growth after successful recanalization', 'timeFrame': 'Between 24 and 48h after the thrombectomy', 'description': 'Quantification of infarctus volume by MRI'}, {'measure': 'Death', 'timeFrame': '3 months after cerebral infarction', 'description': 'Death of the patient'}, {'measure': 'Patient exposure to peak outdoor air pollution', 'timeFrame': '96 hours before cerebral infarction', 'description': 'Quantification of peak outdoor air pollution (identification of the location of the patient and the polluants observed in the areas)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'thrombi', 'metabolites'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years of age or older;\n* Patient with a cerebral infarction documented by brain imaging who received endovascular treatment by mechanical thrombectomy;\n* Patient for whom it was possible to collect cerebral thrombus for LC-MS analysis during mechanical thrombectomy:\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* 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'}, 'identificationModule': {'nctId': 'NCT05658835', 'acronym': 'MATISSE', 'briefTitle': 'Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Interest of Molecular Analysis of Cerebral Thrombi in Determining the Prognosis and Etiology of Cerebral Infarction', 'orgStudyIdInfo': {'id': 'RCAPHM22_0231'}, 'secondaryIdInfos': [{'id': 'ID-RCB', 'type': 'OTHER', 'domain': '2022-A01860-43'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient suffering from ischemic stroke', 'interventionNames': ['Other: Thrombi and blood analyses']}], 'interventions': [{'name': 'Thrombi and blood analyses', 'type': 'OTHER', 'description': 'Thrombi and blood will be collected during thrombectomy', 'armGroupLabels': ['Patient suffering from ischemic stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97261', 'city': 'Fort-de-France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin Bourgeois', 'role': 'CONTACT'}, {'name': 'Cristina Iosif', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Martinique'}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie DOCHE', 'role': 'CONTACT', 'email': 'emilie.doche@ap-hm.fr'}], 'facility': 'Stroke Center', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '97139', 'city': 'Pointe à Pitre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Landais', 'role': 'CONTACT'}], 'facility': 'CHU Guadeloupe', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'city': 'Saint-Pierre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mirebeau Gabriel', 'role': 'CONTACT'}, {'name': 'Julien Dufour', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marc Bindtner', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU La Réunion', 'geoPoint': {'lat': 43.29282, 'lon': 5.40682}}], 'centralContacts': [{'name': 'Emilie Doche', 'role': 'CONTACT', 'email': 'emilie.doche@ap-hm.fr', 'phone': '04 91 38 78 65', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'François Crémieux', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AP-HM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}