Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
Study NCT ID:
NCT03994003
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2019-06-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIO-PREDISC-TIA SWISS Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'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': 'D020521', 'term': 'Stroke'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'MiRNA will be isolated from whole blood collected in PAXgene tubes (BD/PreAnalytiX, Franklin Lakes, NJ). PAXgene tubes contain an RNA stabilizing reagent that acts at time of blood draw to prevent RNA degradation. RNA in whole blood is derived mainly from peripheral blood cells (monocytes, neutrophils, T cells, B cells, and megakaryocytes).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA.', 'timeFrame': '1 year', 'description': 'Diagnostic performance according to PREDISC scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Disease, Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting \\<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting \\<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.\n\n * At least 18 years old.\n * Having given their Informed Consent.\n\nExclusion Criteria:\n\n* ยท Patients with ocular TIA (Amaurosis fugax).\n\n * Patients that still have neurological deficits at the moment of inclusion.\n * Contraindication to perform MRI.\n * For women: pregnancy.'}, 'identificationModule': {'nctId': 'NCT03994003', 'acronym': 'PREDISC', 'briefTitle': 'BIO-PREDISC-TIA SWISS Cohort Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ospedale Civico, Lugano'}, 'officialTitle': 'BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study', 'orgStudyIdInfo': {'id': 'EOC.NSISU.4.12.99'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre hospitalier Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '6900', 'city': 'Lugano', 'state': 'Canton Ticino', 'country': 'Switzerland', 'facility': 'Ospedale Regionale di Lugano', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Carlo Cereda, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. med. Carlo Cereda', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ente Ospedaliero Cantonale, Bellinzona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD Capo Servizio', 'investigatorFullName': 'Dr. med. Carlo Cereda', 'investigatorAffiliation': 'Ospedale Civico, Lugano'}}}}