Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 4:43 PM
Study NCT ID:
NCT01289795
Status:
UNKNOWN
Last Update Posted:
2011-02-04
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, serum, PBMC, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-03', 'studyFirstSubmitDate': '2011-02-03', 'studyFirstSubmitQcDate': '2011-02-03', 'lastUpdatePostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of cEPC', 'timeFrame': '<48h, day 4-5, discharge or day 7', 'description': 'Levels of cEPC (CD34+/CD133+/VEGF2R+/CD31) in % of mononuclear cells using flow cytometry with respect to stroke subtypes.'}], 'secondaryOutcomes': [{'measure': 'Levels of EMP', 'timeFrame': '<48h, day 4-5, day 7 or discharge', 'description': 'Levels of EMP (Annexin V+/CD31+; CD62E+) using flow cytometry with respect to stroke subtypes.'}, {'measure': 'ENDOPAT', 'timeFrame': '<48h, day 4-5,day 7', 'description': 'Digital pulse volume change (with RH PAT as non invasive measurement (PAT-ratio; ENDOPAT, Itamar Medical Ltd.) for non-invasive, peripheral endothelial function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stroke', 'Cerebral Infarction', 'Cerebrovascular Disorders', 'Brain Diseases', 'Central Nervous System Diseases'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether levels of circulating endothelial progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.', 'detailedDescription': 'Endothelial dysfunction is a key component of atherosclerosis which contributes to the development of cardio- and cerebrovascular diseases. However, endothelial dysfunction (ED) is not established as a risk factor for ischemic stroke.\n\nAs a novelty the proposed trial investigates the following variety of indirect markers of endothelial function in acute ischemic stroke:\n\ncirculating endothelial progenitor cells (EPC), endothelial microparticles (EMP), ENDOPAT (RH- PAT ratio) in two regards:\n\n1. time after ischemic events (\\< 48h, Days 4-5, day 7 or at discharge)\n2. etiological stroke subtypes\n\nIt is not known whether these parameters are changed after acute cerebral ischemia and could possibly serve as specific target for treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with first-ever ischemic stroke transferred to our stroke unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with first ever ischemic stroke\n* TIA, or transient symptoms with infarction (TSI)\n* Age \\> or = 18 years old within 24 hours after onset\n* Written informed consent to participate\n* No evidence for dysphagia\n\nExclusion Criteria:\n\n* Malignant hematopoietic disease (e.g. leukemia), severe systemic infections, severe immunological disease, renal or hepatic failure\n* Pancreatitis, cholecystolithiasis, intestinal malabsorption\n* Lactose intolerance\n* Increased risk of aspiration\n* Pregnancy\n* Life expectancy less than 12 months\n* Inability to give written informed consent\n* Psychosis\n* Alcohol dependency\n* Abuse of illegal drugs'}, 'identificationModule': {'nctId': 'NCT01289795', 'acronym': 'EPCAS', 'briefTitle': 'Endothelial Function and Progenitor Cells in Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Endothelial Function and Progenitor Cells in Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'FF_NCRC_EPC01'}, 'secondaryIdInfos': [{'id': '2009-010356-97', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'first-ever ischemic stroke', 'description': 'first-ever ischemic stroke according to the WHO definition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Liman, MD', 'role': 'CONTACT', 'email': 'thomas.liman@charite.de', 'phone': '004930450560643'}, {'name': 'Thomas Liman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Stroke Research Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Thomas Liman, MD', 'role': 'CONTACT', 'email': 'thomas.liman@charite.de', 'phone': '004930450560643'}, {'name': 'Matthias Endres, MD', 'role': 'CONTACT', 'email': 'matthias.endres@charite.de', 'phone': '004930450560102'}], 'overallOfficials': [{'name': 'Matthias Endres, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Stroke Research Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Matthias Endres, MD', 'oldOrganization': 'Center for Stroke Research Berlin'}}}}