Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-30 @ 8:21 PM
Study NCT ID:
NCT01206257
Status:
COMPLETED
Last Update Posted:
2013-06-11
First Post:
2010-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C038192', 'term': 'iopromide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17513}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2010-09-20', 'studyFirstSubmitQcDate': '2010-09-20', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Estimation of the image quality of Ultravist®', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Survey', 'Angiography', 'ADR', 'Image quality'], 'conditions': ['Angiocardiography']}, 'descriptionModule': {'briefSummary': 'This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study\n\nExclusion Criteria:\n\n* Patients who are or are suspected in pregnancy or nursery\n* Patients with the contraindications for Ultravist\n* Patients with the contraindications for cardiac catheterization'}, 'identificationModule': {'nctId': 'NCT01206257', 'acronym': 'TRUST', 'briefTitle': 'The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.', 'orgStudyIdInfo': {'id': '15454'}, 'secondaryIdInfos': [{'id': 'UV1010CN', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Iopromide (Ultravist, BAY86-4877)']}], 'interventions': [{'name': 'Iopromide (Ultravist, BAY86-4877)', 'type': 'DRUG', 'description': 'Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'China'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Director', 'oldOrganization': 'Bayer Healthcare AG'}}}}