Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT02143102
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-invasive Computer-Aided Phenotyping of Vasculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], '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'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrew.buckler@elucidbio.com', 'phone': '978-468-0508', 'title': 'Andrew J. Buckler', 'organization': 'Elucid Bioimaging'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from time of enrollment through endarterectomy procedure, an average of 1 month', 'description': 'The study protocol was written to ensure that the study have no effect on either diagnosis or treatment of enrollees.', 'eventGroups': [{'id': 'EG000', 'title': 'Development Set', 'description': 'Data from subjects in the training set will be utilized to further develop the vascuCAP measurements.', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 0, 'seriousNumAtRisk': 86, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Testing Set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testing Set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.'}, {'id': 'OG001', 'title': 'Full', 'description': 'Pooled results for final estimation'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-1.75', 'upperLimit': '0.41'}, {'value': '.07', 'groupId': 'OG001', 'lowerLimit': '-.22', 'upperLimit': '.42'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed on tissue samples collected within 30 days of non-invasive imaging', 'description': 'Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)', 'unitOfMeasure': 'mm2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Testing Set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.'}, {'id': 'OG001', 'title': 'Full', 'description': 'Pooled results for final estimation'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '.12', 'upperLimit': '2.51'}, {'value': '.87', 'groupId': 'OG001', 'lowerLimit': '-.18', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed on tissue samples collected within 30 days of non-invasive imaging', 'description': 'Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)', 'unitOfMeasure': 'mm2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Development Set', 'description': 'Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.'}, {'id': 'FG001', 'title': 'Testing Set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Development Set', 'description': 'Data from subjects in the training set will be utilized to further develop the vascuCAP measurements.'}, {'id': 'BG001', 'title': 'Testing Set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '11', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '66.4', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-03-12', 'size': 1044957, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-09-07T13:09', 'hasProtocol': True}, {'date': '2015-09-08', 'size': 2367464, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-09-07T13:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "After endarterectomy during surgery, the excised plaque specimens will be sent to the hospital's pathology lab to be analyzed."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2014-05-15', 'resultsFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-07', 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.', 'timeFrame': 'Assessed on tissue samples collected within 30 days of non-invasive imaging', 'description': 'Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)'}, {'measure': 'Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.', 'timeFrame': 'Assessed on tissue samples collected within 30 days of non-invasive imaging', 'description': 'Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carotid Atherosclerosis', 'Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '28858564', 'type': 'DERIVED', 'citation': 'Sheahan M, Ma X, Paik D, Obuchowski NA, St Pierre S, Newman WP 3rd, Rae G, Perlman ES, Rosol M, Keith JC Jr, Buckler AJ. Atherosclerotic Plaque Tissue: Noninvasive Quantitative Assessment of Characteristics with Software-aided Measurements from Conventional CT Angiography. Radiology. 2018 Feb;286(2):622-631. doi: 10.1148/radiol.2017170127. Epub 2017 Aug 31.'}]}, 'descriptionModule': {'briefSummary': 'The investigators use MRI and/or CT to evaluate the extent, as well as, the structure, composition, and functional aspects of atherosclerotic plaques in human carotid and femoral arteries in patients scheduled to undergo an endarterectomy of the aforementioned vascular beds as part of their routine clinical care.', 'detailedDescription': 'The investigators hypothesize that in vivo MRI and/or CT examinations of patients, when suitably acquired and analyzed with the vascuCAP™ analysis software, can provide a sufficiently accurate profile of plaque characteristics to provide an objective basis for patient management. Study subjects include patients undergoing endarterectomies to mitigate their clinical risk or symptoms for conditions including stroke, claudication, and critical limb ischemia. The endarterectomy specimens removed at surgery will allow a direct comparison between the MRI information obtained prior to the surgery and the histopathological analyses of the arterial specimens. The vascuCAP™ measurements of structural and functional features of the arterial wall will be performed in patients undergoing endarterectomy. Measured results will be compared in a blinded fashion with histology to assess performance of plaque profiling and build a pilot prediction model for risk scoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:\n\n* Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study\n* Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIndividuals must meet one of the following inclusion criteria in order to be eligible to participate in the study:\n\n* Case subjects will be patients with documented carotid atherosclerosis, scheduled for magnetic resonance or CT angiography and subsequent elective endarterectomy with 30 days of enrollment in the study\n* Case subjects will be patients with peripheral arterial disease (PAD) with clinical symptoms, scheduled for magnetic resonance or CT angiography and indicated endarterectomy of diseased areas of femoral arteries within 30 days of enrollment in the study\n\nExclusion Criteria:\n\n* Subjects with claustrophobia or inability to tolerate prior MRI studies.\n* Subjects with metal implants that are not MRI compatible (LSU detailed checklist to be attached) including: Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.). Subjects with any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.\n* Subjects with a history of kidney disease or dialysis that are unable to receive intravenous gadolinium contrast material.\n* Female subjects. A urine pregnancy test will be required of all female subjects of childbearing potential prior to inclusion in this study. Pregnant or nursing females will be excluded from the study.\n* Subjects who cannot adhere to the experimental protocol.\n* Subjects allergic to contrast material.'}, 'identificationModule': {'nctId': 'NCT02143102', 'acronym': 'Q-CAMP', 'briefTitle': 'Non-invasive Computer-Aided Phenotyping of Vasculopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elucid Bioimaging Inc.'}, 'officialTitle': 'vascuCAP: Non-invasive Computer-Aided Phenotyping of Vasculopathy', 'orgStudyIdInfo': {'id': '305'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training set', 'description': 'Data from subjects in the training set will be utilized to further develop the vascuCAPTM classifiers.'}, {'label': 'Testing set', 'description': 'Data from subjects in the testing set will be used to assess the study endpoints.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'facility': 'West Jefferson Medical Center', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU ILH', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Andrew J. Buckler, M.S.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Elucid Biomaging Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elucid Bioimaging Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}