Carotid Plaque ImagingNCT02749916
Contrast Enhanced SWI for Carotid Plaque Imaging
An observational study of Carotid Plaque Imaging, run by Hyun Seok Choi, M.D. at 2 sites in South Korea.
Trial summary
This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carotid Plaque Imaging
- What is being tested?
- Methods of carotid wall imaging
- How many people
- 25 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2016to Dec 2019
- How long will I take part?
- 1 Week
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute or recent (within 3months) stroke or TIA (transient ischaemic attack)
Who may be able to join
- Patients with acute or recent (within 3months) stroke or TIA
- 50-99% stenosis of internal carotid artery by NASCET criteria
- Written informed consent, prior to registration
Who cannot join
- Hemorrhagic stroke
- Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
- Contraindication for MR imaging
- Hypersensitivity to gadolinium based contrast media
- Pregnant or lactating women
- Patients under age of 19-year-old
- Renal condition : eGFR < 60
- Patients unable and/or unwilling to comply with treatment or study instructions.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center
Seoul
Seoul St. Mary's Hospital
Seoul
About this study
Official title: Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque
This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.
Read the detailed description
Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.
- Conditions
- Carotid Plaque Imaging
- Being tested
- Methods of carotid wall imaging
- Keywords
- SWI, MP-RAGE, DANTE T1-SPACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methods of carotid wall imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute or recent (within 3months) stroke | Not described Receives: Other: Methods of carotid wall imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of findings of vulnerable carotid plaque
Measured: within 3 days after enrollment
Secondary outcomes (1)
Accuracy in delinating geometry of carotid inner lumen and outer wall
Diameter of inner lumen and outer wall; Area of inner lumen and outer wall
Measured: within 3 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Plaque ImagingStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hyun Seok Choi, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Seok Choi, M.D., Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749916
- Sponsor's protocol ID
- KC15EIMI0104
- Status last verified
- Sep 2019
- First submitted
- 19 Apr 2016
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Susceptibility Weighted Imaging (SWI) for Characterization of Carotid Plaque
- ClinicalTrials.gov ID
- NCT02749916
- Acronym / sponsor ID
- KC15EIMI0104
- Conditions
- Carotid Plaque Imaging
- Keywords
- SWI, MP-RAGE, DANTE T1-SPACE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hyun Seok Choi, M.D.University, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Apr 2016 (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.
This study aims to compare image-based characteristics of carotid walls between symptomatic side and the opposite side. The design of this study is phase IV, prospective observational study.
Detailed description
Atherosclerosis of craniocervical arteries are one of most important causes of stroke. Carotid artery is the most frequent site of atherosclerosis. Recent research in carotid artery covers not only morphology of lumen but also direct visualization of carotid plaque or vessel wall. Vulnerable carotid plaques share pathologic features of intra-plaque inflammation and hemorrhage. There have been reports about post-contrast SWI in the field of vascular imaging. We hypothesized SWI is so sensitive to gadolinium based contrast agent and hemorrhage that contrast-enhanced SWI can visualize vulnerable carotid plaque. The purpose of this study is to investigate gadolinium-enhanced SWI in detection of vulnerable carotid plaque and compare it with MP-RAGE and DANTE T1-SPACE. This can be used to guide proper treatment for stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute or recent (within 3months) stroke | – | Other: Methods of carotid wall imaging |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute or recent (within 3months) stroke or TIA (transient ischaemic attack)
Key inclusion criteria (3 listed)
- Patients with acute or recent (within 3months) stroke or TIA
- 50-99% stenosis of internal carotid artery by NASCET criteria
- Written informed consent, prior to registration
Key exclusion criteria (8 listed)
- Hemorrhagic stroke
- Previous history of carotid endarterectomy (CEA), angioplasty, or stenting
- Contraindication for MR imaging
- Hypersensitivity to gadolinium based contrast media
- Pregnant or lactating women
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 |
|---|---|---|
| Methods of carotid wall imaging | Other | Patients with acute or recent (within 3months) stroke |
Primary outcome
Detection rate of findings of vulnerable carotid plaque
Time frame: within 3 days after enrollment
1 secondary outcome
Accuracy in delinating geometry of carotid inner lumen and outer wall
Time frame: within 3 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Imaging, run by Hyun Seok Choi, M.D. at 2 sites in South Korea.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Results are not available in the source record.
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?
Detection rate of findings of vulnerable carotid plaque (time frame: within 3 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2019.