Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-01 @ 5:14 AM
Study NCT ID:
NCT03157934
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional outcome', 'timeFrame': '3 months after intervention', 'description': 'Functional outcome according to the modified Rankin Scale (mRS)'}], 'secondaryOutcomes': [{'measure': 'Number of patients receiving acute recanalisation therapies of all referrals', 'timeFrame': '24 h after stroke onset', 'description': 'Number of patients receiving thrombolysis and/or thrombectomy of all patients included in to the Network via the database.'}, {'measure': 'Referral rates', 'timeFrame': 'Stroke onset to discharge from acute hospital; through study completion, an average of 2 years', 'description': 'Referral rates by stroke service level (i.e. type of treatment center)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke network', 'acute stroke care', 'emergency medical services', 'integrated care'], 'conditions': ['Ischemic Stroke', 'Vascular Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.researchgate.net/project/FAST-STROKE-CONSORTIUM-RHINE-NECKAR', 'label': 'FAST on ResearchGate'}, {'url': 'https://twitter.com/FAST_Heidelberg', 'label': 'FAST on Twitter'}, {'url': 'http://www.fast-schlaganfall.de', 'label': 'FAST Website with download Resources'}]}, 'descriptionModule': {'briefSummary': 'FAST is an investigator-initiated multicenter study embedded in a German multistate acute stroke network. The main objectives of the FAST study are to improve outcomes and quality of care for stroke patients, to quantify the number of patients in need of thrombectomy within an integrated stroke network, to study the best way of delivering and performing thrombectomy and to investigate the best model of pre-hospital selection and referral for stroke patients.', 'detailedDescription': 'Since 2015, mechanical thrombectomy in patients with large vessel occlusion has become an evidence based highly efficient treatment. In contrast to thrombolysis, thrombectomy can only be delivered by qualified interventionalists at comprehensive stroke centers. Thus, the implementation of thrombectomy into clinical practice remains a challenge. The investigators aim to establish a population based approach within a patient registry in a federal state overarching regional stroke network covering over 4 million inhabitants and integrating approximately 30 hospitals with different levels of expertise. The registry will include data from all acute ischemic stroke patients - approx. 12.000 patients p.a - within the network. The investigators plan to establish a central multi-interface platform integrating clinical data from the prehospital, intrahospital and rehabilitation phase including mandatory quality assurance, neurological and neuroradiological treatment and outcome data. The registry will allow addressing important questions, such as how many patients are candidates for thrombectomy, how many resources are needed to meet that demand and how treatment procedures and times can be improved. The overarching aim is to deliver high quality stroke care to every patient in the region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute stroke patients admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Patients with ischemic stroke who are admitted to one of the hospitals of the Stroke Consortium Rhein-Neckar (FAST)\n* informed consent\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT03157934', 'acronym': 'FAST', 'briefTitle': 'Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Heidelberg'}, 'officialTitle': 'Schlaganfallkonsortium Rhein-Neckar (Stroke Consortium Rhine-Neckar)', 'orgStudyIdInfo': {'id': 'FAST'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary CSC (Comprehensive Stroke center) admission', 'description': 'Patients with primary admission to endovascular-ready hospital (comprehensive stroke center)', 'interventionNames': ['Other: not applicable (observational study)']}, {'label': 'Primary non-CSC (non-Comprehensive Stroke Center) SU (Stroke Unit) admission', 'description': 'Patients with primary admission to non-endovascular-ready hospital with (regional/local) stroke unit', 'interventionNames': ['Other: not applicable (observational study)']}, {'label': 'Non-acute stroke hospital admission', 'description': 'Patients with primary admission to non-acute stroke-ready hospital', 'interventionNames': ['Other: not applicable (observational study)']}], 'interventions': [{'name': 'not applicable (observational study)', 'type': 'OTHER', 'description': 'Observational study without study related intervention', 'armGroupLabels': ['Non-acute stroke hospital admission', 'Primary CSC (Comprehensive Stroke center) admission', 'Primary non-CSC (non-Comprehensive Stroke Center) SU (Stroke Unit) admission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Loraine Busetto, Dr.', 'role': 'CONTACT', 'email': 'loraine.busetto@med.uni-heidelberg.de', 'phone': '+49622156', 'phoneExt': '34149'}], 'facility': 'Heidelberg University Hospital', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Loraine Busetto, Dr.', 'role': 'CONTACT', 'email': 'loraine.busetto@med.uni-heidelberg.de', 'phone': '+49622156', 'phoneExt': '34149'}, {'name': 'Maja Zenz, PhD', 'role': 'CONTACT', 'email': 'maja.zenz@med.uni-heidelberg.de', 'phone': '+49622156', 'phoneExt': '34391'}], 'overallOfficials': [{'name': 'Wolfgang Wick, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Subject to approval by ethics committee'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dietmar Hopp Stiftung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of the Neurologic Clinic', 'investigatorFullName': 'Prof. Dr. Wolfgang Wick', 'investigatorAffiliation': 'University Hospital Heidelberg'}}}}