Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-23 @ 12:30 AM
Study NCT ID:
NCT03268668
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2017-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2017-08-29', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between the composition of the thrombus responsible for stroke, the plasma composition and the stroke characteristics (etiology, response to treatment, prognosis).', 'timeFrame': '3 months', 'description': 'Since this is an observational, exploratory study that correlates laboratory data (eg for thrombus: fibrinolytic, pro-oxidant activity, eg for blood: plasma fibrinolysis markers, presence of factor Von Willebrand, etc.) and clinical data (characteristics of the stroke, including the TOAST etiological score, the TICI score (TICI = thrombolysis in cerebral infarction), the NIHSS score, etc.), there is no single primary endpoint.\n\nClinical data will be collected up to 3 months after stroke (Rankin score).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Acute', 'Biological Specimen Banks', 'Biomarkers', 'Etiology', 'Prognosis']}, 'referencesModule': {'references': [{'pmid': '32811390', 'type': 'DERIVED', 'citation': 'Di Meglio L, Desilles JP, Solonomenjanahary M, Labreuche J, Ollivier V, Dupont S, Deschildre C, Maacha MB, Consoli A, Lapergue B, Piotin M, Blanc R, Ho-Tin-Noe B, Mazighi M; compoCLOT study groupdagger. DNA Content in Ischemic Stroke Thrombi Can Help Identify Cardioembolic Strokes Among Strokes of Undetermined Cause. Stroke. 2020 Sep;51(9):2810-2816. doi: 10.1161/STROKEAHA.120.029134. Epub 2020 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'The recent validation of thrombectomy in addition to thrombolysis with intravenous administration of alteplase suggests a major revolution in the management of acute strokes. This treatment option also opens up a new field of research, making possible the analysis of the clot responsible for intracranial occlusion. Indeed, in about 30% of the cases, the thrombectomy procedure makes it possible to retrieve either partially or completely the clot. Previous studies have analyzed the correlation between the composition of the thrombus and the etiology of stroke. Their discordant results do not yet make it possible to distinguish a particular profile of thrombus according to etiology. Other studies have shown a correlation between the proportion of red blood cells in a thrombus and the likelihood that it is visible in MRI or cerebral scanning. More recently, one study has demonstrated a correlation between the presence of lymphocytes in the thrombus and an atheromatous etiology.\n\nThe main limitations of these studies are the small number of patients included, the high variability of conservation protocols and the absence of plasma data, which does not allow for research on the correlation between clot composition and plasma biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 18 years and older; having a cerebral infarction following arterial occlusion; treated by thrombectomy; patient in whom a thrombus could be collected.\n\nExclusion Criteria:\n\n* Patient benefiting from a legal protection measure; pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT03268668', 'acronym': 'COMPO-CLOT', 'briefTitle': 'Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Thrombus Composition in Ischemic Stroke: Analysis of the Correlation With Plasma Biomarkers, Efficacy of Treatment, Etiology and Prognosis', 'orgStudyIdInfo': {'id': 'JDS_2017_8'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collection of thrombus that is responsible for stroke and blood sample', 'type': 'OTHER', 'description': 'A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :\n\nA) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase \\> 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gaultier MARNAT', 'role': 'CONTACT'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte Barbier', 'role': 'CONTACT'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '87000', 'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aymeric Rouchaud, Pr', 'role': 'CONTACT'}], 'facility': 'Chu Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin GORY', 'role': 'CONTACT'}], 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44 093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain BOURCIER', 'role': 'CONTACT'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75019', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Philippe Désilles, MD', 'role': 'CONTACT', 'email': 'jdesilles@for.paris', 'phone': '0672872906'}], 'facility': 'Fondation Ophtalmologique A. de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François EUGENE', 'role': 'CONTACT'}], 'facility': 'CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '92 150', 'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand LAPERGUE', 'role': 'CONTACT'}], 'facility': 'Hôpital Foch,', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '83000', 'city': 'Toulon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Quentin Holay, MD', 'role': 'CONTACT'}], 'facility': "Hôpital d'Instruction des Armées Sainte-Anne", 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}], 'centralContacts': [{'name': 'Amélie Yavchitz, MD PhD', 'role': 'CONTACT', 'email': 'ayavchitz@for.paris', 'phone': '0148036454', 'phoneExt': '+33'}, {'name': 'Jean-Philippe Désilles, MD', 'role': 'CONTACT', 'email': 'jpdesilles@for.paris', 'phone': '0672872906'}], 'overallOfficials': [{'name': 'Jean-Philippe Désilles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ophtalmologique A. de Rothschild'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}