Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-09 @ 1:22 AM
Study NCT ID:
NCT03335033
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Urban.Matthew@mayo.edu', 'phone': '507-284-3703', 'title': 'Matthew W. Urban', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from baseline to end of study, approximately 36 months', 'eventGroups': [{'id': 'EG000', 'title': 'Carotid Plaques With >70% Stenosis', 'description': 'Subjects who had a plaque causing a \\> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Carotid Plaques With 50-69% Stenosis', 'description': 'Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Completed All of the Ultrasound Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotid Plaques With >70% Stenosis', 'description': 'Subjects who had a plaque causing a \\> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}, {'id': 'OG001', 'title': 'Carotid Plaques With 50-69% Stenosis', 'description': 'Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year after recruitment', 'description': 'Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carotid Plaques With >70% Stenosis', 'description': 'Subjects who had a plaque causing a \\> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}, {'id': 'FG001', 'title': 'Carotid Plaques With 50-69% Stenosis', 'description': 'Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carotid Plaques With >70% Stenosis', 'description': 'Subjects who had a plaque causing a \\> 70% stenosis were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}, {'id': 'BG001', 'title': 'Carotid Plaques With 50-69% Stenosis', 'description': 'Subjects with moderate (50-69% diameter) stenosis carotid plaques were approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.\n\nContrast-enhanced ultrasound: Subjects received a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also, use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.\n\nShear Wave Elastography: Shear wave elastography as performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes.\n\nUltrasound Examination: A standard carotid US examination using Duplex imaging was performed using a linear array transducer to obtain longitudinal and transverse images. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '76.5', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '76.8', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-24', 'size': 1420939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-31T14:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2017-10-04', 'resultsFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2017-11-06', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-01', 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Completed All of the Ultrasound Examinations', 'timeFrame': '1 year after recruitment', 'description': 'Total number of subjects who completed all of the ultrasound examinations to determine visualization of arterial wall (contrast-enhanced ultrasound, 3-D volume ultrasound) and its mechanical properties (shear wave elastography).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Carotid Plaque', 'Contrast Enhanced Ultrasound', 'Shear Wave Elastography', 'Endarterectomy', 'Stenosis'], 'conditions': ['Carotid Artery Plaque']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.', 'detailedDescription': 'All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has carotid plaque with \\> 50% stenosis\n* Subject is able to understand the study procedure and provide informed consent\n\nExclusion Criteria:\n\n* Subject is pregnant or breast feeding\n* Subject is unable to provide informed consent\n* Subject has contraindication to the use of the Lumason contrast agent.'}, 'identificationModule': {'nctId': 'NCT03335033', 'briefTitle': 'New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'New Technologies to Determine Carotid Plaque Vulnerability: A Pilot Study to Assess Contrast-Enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) in Patients With Significant Carotid Plaques', 'orgStudyIdInfo': {'id': '17-001863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid Plaques with >70% Stenosis', 'description': 'Subjects being seen in the Mayo Clinic Gonda Vascular Center who have a plaque causing a \\> 70% stenosis will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.', 'interventionNames': ['Combination Product: Contrast-enhanced ultrasound', 'Device: Shear Wave Elastography', 'Device: Ultrasound Examination']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carotid Plaques with 50-69% Stenosis', 'description': 'Cardiovascular high-risk patients with moderate (50-69% diameter) stenosis carotid plaques from the Mayo Clinic Gonda Vascular Center will be approached for recruitment to receive an ultrasound examination including duplex imaging, shear wave elastography and contrast-enhanced ultrasound.', 'interventionNames': ['Combination Product: Contrast-enhanced ultrasound', 'Device: Shear Wave Elastography', 'Device: Ultrasound Examination']}], 'interventions': [{'name': 'Contrast-enhanced ultrasound', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Lumason'], 'description': 'Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.', 'armGroupLabels': ['Carotid Plaques with 50-69% Stenosis', 'Carotid Plaques with >70% Stenosis']}, {'name': 'Shear Wave Elastography', 'type': 'DEVICE', 'description': 'Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.', 'armGroupLabels': ['Carotid Plaques with 50-69% Stenosis', 'Carotid Plaques with >70% Stenosis']}, {'name': 'Ultrasound Examination', 'type': 'DEVICE', 'description': 'A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.', 'armGroupLabels': ['Carotid Plaques with 50-69% Stenosis', 'Carotid Plaques with >70% Stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Matthew W Urban', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew W. Urban', 'investigatorAffiliation': 'Mayo Clinic'}}}}