Carotid Plaque Hemorrhage Appearance3TMRNCT02335567
Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
An observational study of Carotid Plaque Hemorrhage Appearance, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Plaque Hemorrhage Appearance
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3 tesla MRI imaging.
Who may be able to join
- Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging
Who cannot join
- Patients that are determined to no be safe to undergo MR imaging due to implants
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University - Department of Radiology
East Lansing, Michigan, 48824
About this study
To compare two competing newly designed 3D sequences for black blood carotid plaque imaging techniques with the industry standard 2D sequnce for black blood.
Read the 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.
- Conditions
- Carotid Plaque Hemorrhage Appearance
- Being tested
- there is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of intraplaque hemorrhage
what radiologist interperts
Measured: 1 day of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJun 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carotid Plaque Hemorrhage AppearanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin DeMarco, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335567
- Sponsor's protocol ID
- GE sequence
- Acronym
- 3TMR
- Status last verified
- Sep 2016
- First submitted
- 7 Jan 2015
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23194832DeMarco 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.
PubMed 22548930Mughal 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.
PubMed 21985544Ota 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.
PubMed 20616325Underhill 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.
PubMed 20093315DeMarco 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.
PubMed 24380475Zhu 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.
PubMed 20574968Zhu 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.
PubMed 18583079
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of in Vivo 3T MR to Characterize Carotid Plaque in Patients and Correlate MR Findings With Symptoms
- ClinicalTrials.gov ID
- NCT02335567
- Acronym / sponsor ID
- 3TMR / GE sequence
- Conditions
- Carotid Plaque Hemorrhage Appearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with 50% asymptomatic stenosis of the carotid artery that are safe to undergo 3 tesla MRI imaging.
Key inclusion criteria (1 listed)
- Patients with 50% stenosis of the carotid arteries that are safe to undergo MRI imaging
Key exclusion criteria (1 listed)
- Patients that are determined to no be safe to undergo MR imaging due to implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no intervention | Other | – |
Primary outcome
Appearance of intraplaque hemorrhage
Time frame: 1 day of scan
what radiologist interperts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Background: PubMed 23194832Ota 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.
- Background: PubMed 22548930DeMarco 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.
- Background: PubMed 21985544Mughal 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.
- Background: PubMed 20616325Ota 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.
- Background: PubMed 20093315Underhill 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.
- Results publication: PubMed 24380475DeMarco 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.
- Results publication: PubMed 20574968Zhu 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.
- Results publication: PubMed 18583079Zhu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Plaque Hemorrhage Appearance, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of intraplaque hemorrhage (time frame: 1 day of scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02335567, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.