Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-03-19 @ 5:41 PM
Study NCT ID:
NCT01947335
Status:
COMPLETED
Last Update Posted:
2016-06-15
First Post:
2013-01-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IVUS Guidance to Reduce Contrast in Coronary Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018084', 'term': 'Ultrasonography, Interventional'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pedro.lemos@incor.usp.br', 'phone': '+55 11 2661 5000', 'title': 'Dr. Pedro A. Lemos', 'organization': 'Heart Institute (Incor)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Patients were enrolled according to somewhat restricted criteria, which excluded patients with recent catheterization, using nephrotoxic agents, or with unstable or unknown renal function.'}}, 'adverseEventsModule': {'timeFrame': 'In-hospital', 'eventGroups': [{'id': 'EG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention', 'otherNumAtRisk': 42, 'otherNumAffected': 8, 'seriousNumAtRisk': 42, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention', 'otherNumAtRisk': 41, 'otherNumAffected': 3, 'seriousNumAtRisk': 41, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Peak increase in creatinine > 0.5mg/dl', 'notes': 'Peak increase in creatinine \\> 0.5mg/dl', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Periprocedural Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unplanned revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stent Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Volume of Iodine Contrast Used During Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'id': 'OG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '97.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1', 'description': 'Total volume of iodine contrast administered during the index procedure.', 'unitOfMeasure': 'ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Adverse Cardiac Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'id': 'OG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention'}], 'classes': [{'title': '30 days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days and 6 months', 'description': 'Composite of death, myocardial infarction or repeat revascularization', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Contrast-induced Nephropathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'id': 'OG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Increase \\>= 0.5 mg/dl in basal serum creatinine', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'id': 'FG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'id': 'BG001', 'title': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention\n\nIVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'groupId': 'BG000', 'lowerLimit': '57.3', 'upperLimit': '76.5'}, {'value': '67.1', 'groupId': 'BG001', 'lowerLimit': '58.3', 'upperLimit': '76.1'}, {'value': '64.6', 'groupId': 'BG002', 'lowerLimit': '57.3', 'upperLimit': '76.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-06', 'studyFirstSubmitDate': '2013-01-01', 'resultsFirstSubmitDate': '2016-05-06', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-06', 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Volume of Iodine Contrast Used During Procedure', 'timeFrame': 'Day 1', 'description': 'Total volume of iodine contrast administered during the index procedure.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiac Events', 'timeFrame': '30 days and 6 months', 'description': 'Composite of death, myocardial infarction or repeat revascularization'}, {'measure': 'Incidence of Contrast-induced Nephropathy', 'timeFrame': '7 days', 'description': 'Increase \\>= 0.5 mg/dl in basal serum creatinine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary', 'Angioplasty', 'Percutaneous coronary intervention', 'Stent', 'Contrast', 'Acute Renal failure', 'Intravascular ultrasound', 'Prevention'], 'conditions': ['Contrast Media Reaction', 'Acute Renal Failure']}, 'referencesModule': {'references': [{'pmid': '25326742', 'type': 'DERIVED', 'citation': 'Mariani J Jr, Guedes C, Soares P, Zalc S, Campos CM, Lopes AC, Spadaro AG, Perin MA, Filho AE, Takimura CK, Ribeiro E, Kalil-Filho R, Edelman ER, Serruys PW, Lemos PA. Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. JACC Cardiovasc Interv. 2014 Nov;7(11):1287-93. doi: 10.1016/j.jcin.2014.05.024. Epub 2014 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.', 'detailedDescription': 'Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence. The final volume of contrast media utilized during the procedure is a well-known independent factor affecting the occurrence of CI-AKI.\n\nIntravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI.\n\nIn the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Age \\>=18 years\n* Coronary artery disease scheduled for percutaneous intervention\n* Technical feasibility for intravascular ultrasound to guide coronary angioplasty\n* Increased risk for contrast-induced acute renal failure (e.g. age \\> 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney)\n\nExclusion Criteria:\n\n* Anticipated technical impossibility for intravascular ultrasound\n* Unknown baseline renal function\n* Baseline end-stage renal failure needing dialysis\n* Acute renal failure with dynamic change in renal function at the time of index procedure\n* Iodine contrast administration \\<= 72 prior to index procedure\n* Known allergy to iodine contrast'}, 'identificationModule': {'nctId': 'NCT01947335', 'acronym': 'MOZART', 'briefTitle': 'IVUS Guidance to Reduce Contrast in Coronary Angioplasty', 'organization': {'class': 'OTHER', 'fullName': 'InCor Heart Institute'}, 'officialTitle': 'Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study', 'orgStudyIdInfo': {'id': '02358512.7.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Angiography-guided PCI', 'description': 'Angiography-guided percutaneous coronary intervention'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVUS-guided PCI', 'description': 'Intravascular ultrasound guided percutaneous coronary intervention', 'interventionNames': ['Device: IVUS-guided PCI']}], 'interventions': [{'name': 'IVUS-guided PCI', 'type': 'DEVICE', 'otherNames': ['Intravascular ultrasound'], 'description': 'Intravascular ultrasound guided percutaneous coronary intervention', 'armGroupLabels': ['IVUS-guided PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Institute - InCor. University of Sao Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Pedro A Lemos, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Institute - InCor. University of Sao Paulo Medical School'}, {'name': 'Paulo R Soares, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute - InCor. University of Sao Paulo Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InCor Heart Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Pedro A. Lemos', 'investigatorAffiliation': 'InCor Heart Institute'}}}}