Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02335567
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2015-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-15', 'studyFirstSubmitDate': '2015-01-07', 'studyFirstSubmitQcDate': '2015-01-08', 'lastUpdatePostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appearance of intraplaque hemorrhage', 'timeFrame': '1 day of scan', 'description': 'what radiologist interperts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Carotid Plaque Hemorrhage Appearance']}, 'referencesModule': {'references': [{'pmid': '23194832', 'type': 'BACKGROUND', 'citation': 'Ota H, Reeves MJ, Zhu DC, Majid A, Collar A, Yuan C, DeMarco JK. Sex differences of high-risk carotid atherosclerotic plaque with less than 50% stenosis in asymptomatic patients: an in vivo 3T MRI study. AJNR Am J Neuroradiol. 2013 May;34(5):1049-55, S1. doi: 10.3174/ajnr.A3399. Epub 2012 Nov 29.'}, {'pmid': '22548930', 'type': 'BACKGROUND', 'citation': 'DeMarco JK, Willinek WA, Finn JP, Huston J 3rd. Current state-of-the-art 1.5 T and 3 T extracranial carotid contrast-enhanced magnetic resonance angiography. Neuroimaging Clin N Am. 2012 May;22(2):235-57, x. doi: 10.1016/j.nic.2012.02.007.'}, {'pmid': '21985544', 'type': 'BACKGROUND', 'citation': 'Mughal MM, Khan MK, DeMarco JK, Majid A, Shamoun F, Abela GS. Symptomatic and asymptomatic carotid artery plaque. Expert Rev Cardiovasc Ther. 2011 Oct;9(10):1315-30. doi: 10.1586/erc.11.120.'}, {'pmid': '20616325', 'type': 'BACKGROUND', 'citation': 'Ota H, Reeves MJ, Zhu DC, Majid A, Collar A, Yuan C, DeMarco JK. Sex differences in patients with asymptomatic carotid atherosclerotic plaque: in vivo 3.0-T magnetic resonance study. Stroke. 2010 Aug;41(8):1630-5. doi: 10.1161/STROKEAHA.110.581306. Epub 2010 Jul 8.'}, {'pmid': '20093315', 'type': 'BACKGROUND', 'citation': 'Underhill HR, Hatsukami TS, Cai J, Yu W, DeMarco JK, Polissar NL, Ota H, Zhao X, Dong L, Oikawa M, Yuan C. A noninvasive imaging approach to assess plaque severity: the carotid atherosclerosis score. AJNR Am J Neuroradiol. 2010 Jun;31(6):1068-75. doi: 10.3174/ajnr.A2007. Epub 2010 Jan 21.'}, {'pmid': '24380475', 'type': 'RESULT', 'citation': 'DeMarco JK, Huston J 3rd. Imaging of high-risk carotid artery plaques: current status and future directions. Neurosurg Focus. 2014 Jan;36(1):E1. doi: 10.3171/2013.10.FOCUS13384.'}, {'pmid': '20574968', 'type': 'RESULT', 'citation': 'Zhu DC, Vu AT, Ota H, DeMarco JK. An optimized 3D spoiled gradient recalled echo pulse sequence for hemorrhage assessment using inversion recovery and multiple echoes (3D SHINE) for carotid plaque imaging. Magn Reson Med. 2010 Nov;64(5):1341-51. doi: 10.1002/mrm.22517.'}, {'pmid': '18583079', 'type': 'RESULT', 'citation': 'Zhu DC, Ferguson MS, DeMarco JK. An optimized 3D inversion recovery prepared fast spoiled gradient recalled sequence for carotid plaque hemorrhage imaging at 3.0 T. Magn Reson Imaging. 2008 Dec;26(10):1360-6. doi: 10.1016/j.mri.2008.05.002. Epub 2008 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'To compare two competing newly designed 3D sequences for black blood carotid plaque imaging techniques with the industry standard 2D sequnce for black blood.', 'detailedDescription': "To utilize a 3D sequence instead of the usual 2D commonly standard industry sequence that is supplied by the various manufacturers.\n\nPatients with greater than 50% stenosis that are 3T compatible are imaged using the two sequences to compare which sequences better visualize the plaque and it's characteristics\n\nThe purpose is to validate the ability of the new 3D sequence to detect and measure any plaque hemorrhage as well as to identify region sof Type 1 hemorrhage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3 tesla MRI imaging.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging\n\nExclusion Criteria:\n\n* Patients that are determined to no be safe to undergo MR imaging due to implants'}, 'identificationModule': {'nctId': 'NCT02335567', 'acronym': '3TMR', 'briefTitle': 'Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms', 'orgStudyIdInfo': {'id': 'GE sequence'}}, 'armsInterventionsModule': {'interventions': [{'name': 'there is no intervention', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48824', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University - Department of Radiology', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kevin DeMarco', 'investigatorAffiliation': 'Michigan State University'}}}}