Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms

Carotid Plaque Hemorrhage Appearance Clinical Trial

— 3TMR  

Official title:

Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335567
• Other study ID #: GE sequence
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: September 15, 2016
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Carotid Plaque Hemorrhage Appearance
• Hemorrhage

Intervention

Other:
• there is no intervention

Locations

Country	Name	City	State
United States	Michigan State University - Department of Radiology	East Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Michigan State University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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 — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appearance of intraplaque hemorrhage	what radiologist interperts	1 day of scan	No