Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-30 @ 5:54 PM
Study NCT ID:
NCT01363856
Status:
UNKNOWN
Last Update Posted:
2011-06-02
First Post:
2011-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples with DNA whole blood, serum, RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-01', 'studyFirstSubmitDate': '2011-05-31', 'studyFirstSubmitQcDate': '2011-06-01', 'lastUpdatePostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death', 'timeFrame': '36 months', 'description': 'This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician.'}], 'secondaryOutcomes': [{'measure': 'Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death', 'timeFrame': '24 months', 'description': 'This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician. In case of death of the patient, evaluation will be based on data from the registry office'}, {'measure': 'Combined vascular endpoint composed of stroke, myocardial infarction, and vascular death', 'timeFrame': '12 months', 'description': 'This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by hospital or physician. In case of death of the patient, evaluation will be based on data from the registry office'}, {'measure': 'Course of cognitive function', 'timeFrame': '36 months', 'description': 'This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician'}, {'measure': 'Course of depression', 'timeFrame': '36 months', 'description': 'This evaluation will be based on a structured interview with the patient. In case of positive screening more information will be obtained by the physician'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['first ever stroke'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '41057606', 'type': 'DERIVED', 'citation': 'Giesers NK, Schaeff V, Gertz K, Endres M, Liman TG. Associations of Soluble Inflammatory and Endothelial Activation Biomarkers with Cognitive Function Over Three Years After Ischemic Stroke-PROSCIS-B. Transl Stroke Res. 2025 Dec;16(6):2249-2257. doi: 10.1007/s12975-025-01388-4. Epub 2025 Oct 8.'}, {'pmid': '40620229', 'type': 'DERIVED', 'citation': 'Rios AS, Temuulen U, Khalil AA, Villringer K, Ali HF, Akdeniz A, Grittner U, Becher M, Rackoll T, Nave AH, Sperber PS, Liman TG, Otte C, Endres M, Kufner A. Lesion-Network Mapping of Poststroke Depressive Symptoms: Evidence From Two Prospective Ischemic Stroke Cohorts. Stroke. 2025 Sep;56(9):2527-2539. doi: 10.1161/STROKEAHA.125.051858. Epub 2025 Jul 7.'}, {'pmid': '38014691', 'type': 'DERIVED', 'citation': 'Liman TG, Siegerink B, Piper S, Catar R, Moll G, Riemekasten G, Heidecke H, Heuschmann PU, Elkind MSV, Dragun D, Endres M. Vasoregulatory Autoantibodies and Clinical Outcome After Ischemic Stroke-PROSCIS-B. J Am Heart Assoc. 2023 Dec 5;12(23):e032441. doi: 10.1161/JAHA.123.032441. Epub 2023 Nov 28.'}, {'pmid': '37848651', 'type': 'DERIVED', 'citation': 'Schaeff VLK, Sperber PS, Piper SK, Giesers NK, Gertz K, Heuschmann PU, Endres M, Liman TG. Associations of C-reactive protein with depressive symptoms over time after mild to moderate ischemic stroke in the PROSCIS-B cohort. J Neurol. 2024 Feb;271(2):909-917. doi: 10.1007/s00415-023-12038-w. Epub 2023 Oct 18.'}, {'pmid': '36247749', 'type': 'DERIVED', 'citation': 'Stillfried MRV, Sperber PS, Broersen LHA, Huo S, Piper SK, Heuschmann PU, Endres M, Siegerink B, Liman TG. Low ankle-brachial index and cognitive function after stroke-the PROSpective with Incident Stroke Berlin (PROSCIS-B). Front Neurol. 2022 Sep 28;13:963262. doi: 10.3389/fneur.2022.963262. eCollection 2022.'}, {'pmid': '33982599', 'type': 'DERIVED', 'citation': 'Scheitz JF, Lim J, Broersen LHA, Ganeshan R, Huo S, Sperber PS, Piper SK, Heuschmann PU, Audebert HJ, Nolte CH, Siegerink B, Endres M, Liman TG. High-Sensitivity Cardiac Troponin T and Recurrent Vascular Events After First Ischemic Stroke. J Am Heart Assoc. 2021 May 18;10(10):e018326. doi: 10.1161/JAHA.120.018326. Epub 2021 May 13.'}, {'pmid': '33184230', 'type': 'DERIVED', 'citation': 'Huo S, Krankel N, Nave AH, Sperber PS, Rohmann JL, Piper SK, Heuschmann PU, Landmesser U, Endres M, Siegerink B, Liman TG. Endothelial and Leukocyte-Derived Microvesicles and Cardiovascular Risk After Stroke: PROSCIS-B. Neurology. 2021 Feb 9;96(6):e937-e946. doi: 10.1212/WNL.0000000000011223. Epub 2020 Nov 12.'}, {'pmid': '32279621', 'type': 'DERIVED', 'citation': 'Broersen LHA, Siegerink B, Sperber PS, von Rennenberg R, Piper SK, Nolte CH, Heuschmann PU, Endres M, Scheitz JF, Liman TG. High-Sensitivity Cardiac Troponin T and Cognitive Function in Patients With Ischemic Stroke. Stroke. 2020 May;51(5):1604-1607. doi: 10.1161/STROKEAHA.119.028410. Epub 2020 Apr 13.'}, {'pmid': '31526121', 'type': 'DERIVED', 'citation': 'Sperber PS, Siegerink B, Huo S, Rohmann JL, Piper SK, Pruss H, Heuschmann PU, Endres M, Liman TG. Serum Anti-NMDA (N-Methyl-D-Aspartate)-Receptor Antibodies and Long-Term Clinical Outcome After Stroke (PROSCIS-B). Stroke. 2019 Nov;50(11):3213-3219. doi: 10.1161/STROKEAHA.119.026100. Epub 2019 Sep 17.'}, {'pmid': '22928669', 'type': 'DERIVED', 'citation': 'Liman TG, Zietemann V, Wiedmann S, Jungehuelsing GJ, Endres M, Wollenweber FA, Wellwood I, Dichgans M, Heuschmann PU. Prediction of vascular risk after stroke - protocol and pilot data of the Prospective Cohort with Incident Stroke (PROSCIS). Int J Stroke. 2013 Aug;8(6):484-90. doi: 10.1111/j.1747-4949.2012.00871.x. Epub 2012 Aug 29.'}], 'seeAlsoLinks': [{'url': 'http://www.strokecenter.de', 'label': 'Center for Stroke Research Berlin'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to derive and validate risk scores for vascular endpoints (recurrent stroke, myocardial infarction, and other complications of stroke) and for death following an incident stroke. For this purpose patients with an incident stroke will be followed for 36 months with additional assessments at 12, 24 and 36 months.', 'detailedDescription': 'Risk of vascular disease including stroke, myocardial infarction, and vascular death is high after stroke but there are only few prognostic models for long term risk up to 3 years. About 850 patients with an incident stroke will be followed for 3 years with assessments at baseline and at 3, 12, 24, and 36 months. Factors that have already been reported to be significant predictors of vascular diseases in previous studies as well as new biomarkers (e.g. neuroimaging, blood based biomarkers) identified in this cohort will be considered. The improvement of discrimination including these new variables in the models will be investigated. Several measures of improving predictive properties (e.g. calibration, discrimination, net reclassification) will be used to compare predictive models with different complexity. The model will be validated using the bootstrap method (internal validation) and an independent external sample in cooperation with the Institute for Stroke and Dementia Research, Munich.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to a specialized stroke service because of an acute stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Language: German\n* First ever stroke including ischemic stroke, primary intracranial hemorrhage and cerebral venous sinus thrombosis that occurred with stroke onset in the last 7 days\n* Written informed consent by patient prior to study participation\n* Willingness to participate in follow-up\n\nExclusion Criteria:\n\n* Prior stroke (definition according to WHO definition)\n* Patients presenting brain tumour or brain metastasis\n* Participation in an intervention- / AMG-study'}, 'identificationModule': {'nctId': 'NCT01363856', 'acronym': 'CSB_PROSCIS', 'briefTitle': 'Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Center for Stroke Research Berlin (CSB) Prospective Stroke Cohort', 'orgStudyIdInfo': {'id': 'CSB_PROSCIS_01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'First ever acute stroke', 'description': 'Patients over 18 years and without prior stroke according to WHO criteria, displaying an ischemic stroke, onset within the last 7 days, language German'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter U Heuschmann, MD, MPH', 'role': 'CONTACT', 'email': 'peter.heuschmann@charite.de', 'phone': '+49 (0)30 450560611'}, {'name': 'Thomas G Liman, MD', 'role': 'CONTACT', 'email': 'thomas.liman@charite.de', 'phone': '+49 (0)30 450560643'}, {'name': 'Peter U Heuschmann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Dichgans, MD', 'role': 'CONTACT', 'email': 'martin.dichgans@med.uni-muenchen.de', 'phone': '+49 (0)89 7095 Ext. 8310'}], 'facility': 'Interdisciplinary Stroke Center Munich, Klinikum der Universität München, Campus Großhadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Peter U Heuschmann, MD, MPH', 'role': 'CONTACT', 'email': 'peter.heuschmann@charite.dwe', 'phone': '0049 (0)30 450560611'}, {'name': 'Thomas G Liman, MD', 'role': 'CONTACT', 'email': 'thomas.liman@charite.de', 'phone': '49 (0)30 450560643'}], 'overallOfficials': [{'name': 'Peter U Heuschmann, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Stroke Research Berlin, Charité Campus Mitte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinikum der Universitaet Muenchen, Grosshadern', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Matthias Endres, MD', 'oldOrganization': 'Center for Stroke Research Berlin'}}}}