Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT04612218
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2020-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic 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': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-25', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-30', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke subtype diagnostic accuracy', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test'}, {'measure': 'Reperfusion rates', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Times to reperfusion', 'timeFrame': 'through study completion, an average of 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood biomarkers', 'stroke diagnosis', 'stroke', 'biomarkers', 'reperfusion therapies', 'acute stroke therapy', 'prehospital stroke management'], 'conditions': ['Stroke', 'Ischemic Stroke', 'Hemorrhagic Stroke']}, 'descriptionModule': {'briefSummary': "Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years old, in whom health care services activate a stroke code, and the patient is transferred to the reference centre, within 6 hours from symptoms onset.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* I.1: Patients \\> 18 years old.\n* I.2: Stroke code activated by the coordinator centre.\n* I.3: \\< 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.\n\nExclusion Criteria:\n\n* E.1: Prehospital diagnosis different of stroke.\n* E.2: Impossibility of getting a prehospital blood sample.\n* E.3: Refusal to provide the informed consent by the patient/relative.'}, 'identificationModule': {'nctId': 'NCT04612218', 'acronym': 'BIO-FAST', 'briefTitle': 'Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen Macarena'}, 'officialTitle': 'Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)', 'orgStudyIdInfo': {'id': 'BIO-FAST'}}, 'contactsLocationsModule': {'locations': [{'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital de Alta Resolución Sierra Norte', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital San Juan de Dios Aljarafe', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Joan Montaner, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario Virgen Macarena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Alta Resolución Sierra Norte', 'class': 'UNKNOWN'}, {'name': 'Hospital San Juan de Dios Aljarafe', 'class': 'UNKNOWN'}, {'name': 'Hospital Universitario Reina Sofia de Cordoba', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Department of Neurology', 'investigatorFullName': 'Joan Montaner Villalonga', 'investigatorAffiliation': 'Hospital Universitario Virgen Macarena'}}}}