Clinical trial NCT02335567: Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
Official title: Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Plaque Hemorrhage Appearance
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 162
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3 tesla MRI imaging.

Brief summary: To compare two competing newly designed 3D sequences for black blood carotid plaque imaging techniques with the industry standard 2D sequnce for black blood.

Detailed description: To utilize a 3D sequence instead of the usual 2D commonly standard industry sequence that is supplied by the various manufacturers.

Patients 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

The 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.

Eligibility criteria: Inclusion Criteria:

* Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging

Exclusion Criteria:

* Patients that are determined to no be safe to undergo MR imaging due to implants

Primary outcomes:
measure: Appearance of intraplaque hemorrhage
timeFrame: 1 day of scan
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University - Department of Radiology
state: Michigan
Study officials:
References:
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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.
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.
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.
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.
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.