Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-11 @ 4:51 PM
Study NCT ID:
NCT03132558
Status:
UNKNOWN
Last Update Posted:
2017-11-07
First Post:
2017-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Induced Acute Kidney in Patients With Acute Stroke
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003287', 'term': 'Contrast Media'}], 'ancestors': [{'id': 'D064907', 'term': 'Diagnostic Uses of Chemicals'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-04', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinine', 'timeFrame': 'within 24h to 48h', 'description': 'Contrast-induced acute kidney injury was defined as a relative increase of 25% or an absolute increase of 0.3 mg/dL (28.2mol/L) in the serum creatinine level at 48 hours following angiography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke, Acute']}, 'referencesModule': {'references': [{'pmid': '30679214', 'type': 'DERIVED', 'citation': 'Jia ZY, Wang SX, Zhao LB, Cao YZ, Shi HB, Liu S. Risk of Acute Kidney Injury with Consecutive, Multidose Use of Iodinated Contrast in Patients with Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2019 Apr;40(4):652-654. doi: 10.3174/ajnr.A5959. Epub 2019 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'Computed tomographic angiography (CTA) is recommended for identifying eligible patient with acute ischemic stroke (AIS) to receieve endovascular treatment. We are going to conduct this prospective corhot study to observe if sequential use contrast in CTA examination and in endovascular treatment will cause acute kidney injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who are suspected with AIS. Non-contrast head CT excludes intracranial hemorrhage. Patients who receieve CTA or CTA+DSA will be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are suspected with AIS.\n* Non-contrast head CT excludes intracranial hemorrhage.\n\nExclusion Criteria:\n\n* Lacking of pre-CTA Creatinine\n* Lacking of post-angiography Creatinine with 24-48 hours'}, 'identificationModule': {'nctId': 'NCT03132558', 'briefTitle': 'Contrast Induced Acute Kidney in Patients With Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'orgStudyIdInfo': {'id': 'AISAKI001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CTA', 'description': 'Patients with AIS only receieved cerebral CTA exam.', 'interventionNames': ['Drug: Radiopaque Media']}, {'label': 'CTA+DSA', 'description': 'Patients with AIS receieved cerebral CTA, followed by endovascular treatment with the guidence of digital substration angiography (DSA).', 'interventionNames': ['Drug: Radiopaque Media']}], 'interventions': [{'name': 'Radiopaque Media', 'type': 'DRUG', 'armGroupLabels': ['CTA', 'CTA+DSA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hai Bin Shi', 'role': 'CONTACT', 'email': 'shihb@njmu.edu.cn'}, {'name': 'Haibin Shi, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'HaiBin Shi, MD.', 'role': 'CONTACT', 'email': 'shihb@njmu.edu.cn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hai-Bin Shi', 'investigatorAffiliation': 'Nanjing Medical University'}}}}