Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-28 @ 8:47 PM
Study NCT ID:
NCT00812656
Status:
COMPLETED
Last Update Posted:
2009-12-03
First Post:
2008-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-02', 'studyFirstSubmitDate': '2008-12-19', 'studyFirstSubmitQcDate': '2008-12-19', 'lastUpdatePostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in stroke index', 'timeFrame': 'day before surgery; first and second day postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate changes in new plasma stroke biomarker panel in patients undergoing cardiac surgery with the use of cardiopulmonary bypass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing cardiac surgery with the use of cardiopulmonary bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Elective cardiac surgery with the use of cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Patients undergoing emergent procedures\n* Patients with preoperative mechanical support'}, 'identificationModule': {'nctId': 'NCT00812656', 'acronym': 'Stroke08', 'briefTitle': 'Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum Ludwigshafen'}, 'officialTitle': 'Serial Measurement of a Plasma Stroke Biomarker Panel in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'StrokePanel08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke Panel group', 'description': 'Patients undergoing cardiac surgery with the use of cardiopulmonary bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67063', 'city': 'Ludwigshafen', 'state': 'RLP', 'country': 'Germany', 'facility': 'Klinikum Ludwigshafen', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}], 'overallOfficials': [{'name': 'Stefan W Suttner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Ludwigshafen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum Ludwigshafen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. J. Boldt', 'oldOrganization': 'Klinikum Ludwigshafen'}}}}