Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT03149705
Status:
RECRUITING
Last Update Posted:
2020-08-12
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Ischemic STROKE Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'In usual care of patients admitted for ischemic STROKE at Pierre Wertheimer Hospital, blood samples were taken on admission in the neurovascular unit (H0), 6h, 24h and 48h after reperfusion , and during the 3 month clinical visit.\n\nFor the constitution of the serum bank of Hibiscus-STROKE cohort, extra tubes are collected at the same time as the blood tests done routinely.\n\nThese additional samples will be centrifuged and treated to form a collection of biological samples of total serum and plasma and blood stored at the Biological Resource Center of HCL Neurobiotec at -80 ° C (DC- 2008-72, AC-2013-1867 certified NFS96900 FR13-018140).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2017-05-09', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of disability (mRS Score)', 'timeFrame': '5 years', 'description': 'Degree of disability: modified Rankin Score'}], 'secondaryOutcomes': [{'measure': 'infarct size', 'timeFrame': 'day 6', 'description': 'cerebral infarct size on MRI'}, {'measure': 'Hemorrhagic transformation', 'timeFrame': '24 hours', 'description': 'Hemorrhagic transformation (ECASS scale) on imaging (CT or MRI)'}, {'measure': 'Neurological deficit', 'timeFrame': 'up to 5 years', 'description': 'Neurological deficit NIH stroke Scale'}, {'measure': 'Quality of life', 'timeFrame': 'up to 5 years', 'description': 'QOL questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischemic stroke, stroke, bio-collection, Imaging markers, biomarkers, clinical outcomes'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '39391984', 'type': 'DERIVED', 'citation': 'Bani-Sadr A, Hermier M, de Bourguignon C, Mechtouff L, Eker OF, Cappucci M, Tommasino E, Martin A, Cho TH, Derex L, Nighoghossian N, Berthezene Y. Oxygen Extraction Fraction Mapping on Admission Magnetic Resonance Imaging May Predict Recovery of Hyperacute Ischemic Brain Lesions After Successful Thrombectomy: A Retrospective Observational Study. Stroke. 2024 Nov;55(11):2685-2693. doi: 10.1161/STROKEAHA.124.047311. Epub 2024 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'Ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has proven its superiority in this pathology.\n\nCohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool.\n\nThe main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke.\n\nSecondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas:\n\n* Descriptive epidemiology of ischemic stroke and cerebral reperfusion,\n* Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs\n* Assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death,\n* Quality of life and personal, familial, professional and social consequences of stroke,\n* Research of new diagnostic and prognostic biomarkers,\n* Research projects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years\n* Ischemic Stroke confirmed by MRI\n* Proximal arterial occlusion (ICA or M1)\n* Eligible for thrombolysis and/or thrombectomy\n\nExclusion Criteria:\n\n* Patients residing\\> 50 km from the Pierre Wertheimer Hospital (Lyon, France)\n* Inability to perform the first sample (H0)\n* Patient with progressive or uncontrolled cancer.\n* Refusal to participate in the study or to sign the consent\n* Lack of medical social coverage\n* Deprivation of civil rights'}, 'identificationModule': {'nctId': 'NCT03149705', 'acronym': 'HIBISCUSSTROKE', 'briefTitle': 'Cohort of Ischemic STROKE Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.', 'orgStudyIdInfo': {'id': '69HCL17_0323'}}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathan Mewton, MD, PhD', 'role': 'CONTACT', 'email': 'GHE.CICLYON@chu-lyon.fr', 'phone': '+33 472 357 231'}], 'facility': 'Hôpital neurologique Pierre Wertheimer (Lyon)', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Norbert NIGHOGHOSSIAN, Prof', 'role': 'CONTACT', 'email': 'GHE.CICLYON@chu-lyon.fr', 'phone': '+33 4 72 35 71 70'}, {'name': 'Nathan MEWTON, MD, PhD', 'role': 'CONTACT', 'email': 'GHE.CICLYON@chu-lyon.fr', 'phone': '+33 472 357 231'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}