Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-01 @ 10:42 AM
Study NCT ID:
NCT03335995
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Prognosis in Intensive CarE
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-11-07', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': 'One year', 'description': 'Score on the modified Rankin scale (a disability score that ranges from 0 \\[no symptoms\\] to 6 \\[death\\]). Patients will be classified as "good outcome" (score of 0-3) or poor outcome (score of 4-6, indicating severe disability or death).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical invasive ventilation', 'course of the care', 'prognosis', 'stroke'], 'conditions': ['Acute Stroke Patients Requiring Invasive Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '37497675', 'type': 'BACKGROUND', 'citation': 'Sonneville R, Mazighi M, Collet M, Gayat E, Degos V, Duranteau J, Gregoire C, Sharshar T, Naim G, Cortier D, Jost PH, Foucrier A, Bagate F, de Montmollin E, Papin G, Magalhaes E, Guidet B, Ben Hadj Salem O, Benghanem S, le Guennec L, Delpierre E, Legriel S, Megarbane B, Toumert K, Tran M, Geri G, Monchi M, Bodiguel E, Mariotte E, Demoule A, Zarka J, Diehl JL, Roux D, Barre E, Tanaka S, Osman D, Pasquier P, Lamara F, Crassard I, Boursin P, Ruckly S, Staiquly Q, Timsit JF, Woimant F; SPICE Investigators. One-Year Outcomes in Patients With Acute Stroke Requiring Mechanical Ventilation. Stroke. 2023 Sep;54(9):2328-2337. doi: 10.1161/STROKEAHA.123.042910. Epub 2023 Jul 27.'}, {'pmid': '32026446', 'type': 'BACKGROUND', 'citation': 'Sonneville R, Mazighi M, Bresson D, Crassard I, Crozier S, de Montmollin E, Degos V, Faugeras F, Gayat E, Josse L, Lamy C, Magalhaes E, Maldjian A, Ruckly S, Servan J, Vassel P, Vigue B, Timsit JF, Woimant F; SPICE investigators. Outcomes of Acute Stroke Patients Requiring Mechanical Ventilation: Study Protocol for the SPICE Multicenter Prospective Observational Study. Neurocrit Care. 2020 Apr;32(2):624-629. doi: 10.1007/s12028-019-00907-0.'}]}, 'descriptionModule': {'briefSummary': 'The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects included in this study are adult patients requiring invasive mechanical ventilation at the acute phase of stroke (within 7 days of stroke onset), irrespective of indication for intubation.\n\nProlonged mechanical ventilation of several days to weeks in ICU may be required for some patients, with various ICU discharge trajectories in survivors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age\\>18 years\n* Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).\n* Admitted to ICU within 7 days before or after the diagnosis of stroke.\n* Requiring invasive mechanical ventilation in ICU for more than 24 hours.\n\nExclusion criteria:\n\n* Traumatic causes of stroke\n* Refusal of the patient, or his reliable person, to participate in the study.\n* Privation of liberty by administrative or judicial decision'}, 'identificationModule': {'nctId': 'NCT03335995', 'acronym': 'SPICE', 'briefTitle': 'Stroke Prognosis in Intensive CarE', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Stroke Prognosis in Intensive CarE - The SPICE Registry', 'orgStudyIdInfo': {'id': 'C17-16'}}, 'contactsLocationsModule': {'locations': [{'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Bichat Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-François TIMSIT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'U 1137'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}