Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT01639534
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2012-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'An aliquot of each sample will be stored for potentialconfirmatory reanalysis in the future at this or a contracted insitution.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2012-07-10', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers of Ischemia: Levels of Xanthine, Hypoxanthine and Inosine during Carotid Stenting Procedures', 'timeFrame': 'analysis will occur after all samples collected', 'description': 'To compare a new blood test with can help the doctor determine if there is a brain injury or ischemia, The study will measure new biomarkers of neurologic stress called xanthine, hypoxanthine and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in the blood. The blood will be analyzed in the laboratory at VCU.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biomarkers of ischemia', 'Carotid Stenting procedure', 'Levels Xanthine Hypoxanthine and Inosine', 'peripheral blood'], 'conditions': ['Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood', 'Ischemia/Hypoperfusion of Brain']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain. In this study the investigators are analyzing your blood for a new test that might help doctors decide if symptoms are from a neurologic problem.', 'detailedDescription': 'We will compare a new blood test with routine tests that the doctor will order as part of your normal care. This study will measure new biomarkers (biomarker is a specific distinguishing feature used to measure or indicate the effects or progress of a disease or condition) of neurologic stress called xanthine, hypoxanthine, and inosine. Blood will be drawn as a part of the study to measure these biomarker levels in your blood. This blood will be analyzed i the laboratory at Virginia Commonwealth University and possibly at a future date at another institution. No names will be associated with the blood sample'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for Carotid Stenting Procedure at Virginia Commonwealth University', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women over age of 18 non\n* Women who are not pregnant\n* Subject who are not prisoners\n* Subjects presenting to the operation room for a Carotid artery stenting procedure\n* Hemoglobin greater than or equal to 11mg/dl\n* Subjects who speak english\n* Subjects 18 years of age or older\n\nExclusion Criteria:\n\n* Hemoglobin less than 11mg/dl\n* Women who are pregnant\n* Children under age of 18\n* Prisoners\n* Non English'}, 'identificationModule': {'nctId': 'NCT01639534', 'briefTitle': 'Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures', 'orgStudyIdInfo': {'id': 'HM12941'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biomarkers, Carotid Stenting, Blood sample', 'description': 'Subjects requiring Carotid Stenting Procedure at Virginia Commonwealth University/Medical College of Virginia Health Systems'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Lynne Gehr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}