High Resolution Vessel Wall ImagingNCT06404242
Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients
An observational study of High Resolution Vessel Wall Imaging and Recurrent Stroke, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial summary
The epidemiology of TOAST classification in Asian patients seems to differ due to the higher rates of large-artery atherosclerosis. The complex pathology of atherosclerosis could lead to recurrent stroke, including shear stress on the endothelium, disturbance of the flow, occlusion at the origin of the perforating… Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- High Resolution Vessel Wall Imaging, Recurrent Stroke, Stroke, Mechanism
- How many people
- 75 participants
- Where
- 1 siteVietnam
- Study dates
- 27 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators would include patients who had ischemic stroke due to middle cerebral artery (MCA) stenosis (>50%)
Who may be able to join
- Patients who had a first-time ischemic stroke due to MCA atherosclerosis stenosis more than 50% and admitted to our hospital within 7 days after onset.
- Patients are more than 45 years old.
- Patients had HR-MRI and have done the full stroke workup (including carotid duplex scanning, fasting lipid profile, Holter ECG 24 hours, cardiac ultrasound,...)
Who cannot join
- Patients also have stenosis of the carotid artery (more than 50%) or occulsion on the same side of ischemic stroke
- Patients also have an ischemic stroke in territories other than MCA territory.
- Patients had any characteristics that suggested other causes for their stenosis, including moyamoya, dissection, and inflammation on their MRI and HR-MRI.
- Patients with evidence suggestive of cardioembolism (Atrial fibrillation, decreased EF <50%, recent heart attack in 3 weeks, rheumatic valvular heart disease, dilated cardiopathy, sick sinus syndrome, infective endocarditis).
- Any signs suggestive other causes (non atherosclerosis etiology), including autoimmune disease or increased coagulation state.
- Patients with severe concomitant disease could affect the 6-month follow-up of the patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 70000
Khoa Dao, +84986883254, khoa.dd@umc.edu.vn
About this study
Official title: Plaque Characteristics From Vessel Wall Magnetic Resonance Imaging Predict Recurrent Stroke in Ischemic Stroke Patients Due to Middle Cerebral Artery Stenosis
The epidemiology of TOAST classification in Asian patients seems to differ due to the higher rates of large-artery atherosclerosis. The complex pathology of atherosclerosis could lead to recurrent stroke, including shear stress on the endothelium, disturbance of the flow, occlusion at the origin of the perforating artery, and other complications (plaque inflammation, plaque hemorrhage, plaque rupture) that could lead to stroke and recurrent stroke. Therefore, The exact determination of the etiology of stroke due to atherosclerosis is the most critical factor for treatment and prognostic. On the other hand, HR-MRI could be a useful imaging modality to evaluate the characteristics of plaque in stroke patients due to atherosclerosis stenosis, which will help us find out the etiology of stroke. Previous studies have demonstrated its prognosis value in predicting recurrent stroke in the same vascular territory. The investigators hypothesize that with an appropriate evaluation, HR-MRI could help to predict recurrent stroke in the same vascular territory in patients with high-risk plaque characteristics on HR-MRI. These findings could contribute to individual treatment according to etiology.
The investigators intend to conduct a study to determine the correlation between plaque characteristics and recurrent stroke in the same vascular territory in ischemic stroke patients due to middle cerebral artery stenosis.
Read the detailed description
The epidemiology of TOAST classification in Asian patients seems to differ due to the higher rates of large-artery atherosclerosis 1. The complex pathology of atherosclerosis could lead to recurrent stroke, including shear stress on the endothelium, disturbance of the flow, occlusion at the origin of the perforating artery, and other complications (plaque inflammation, plaque hemorrhage, plaque rupture) that could lead to stroke and recurrent stroke 2. Therefore, The exact determination of the etiology of stroke due to atherosclerosis is the most critical factor for treatment and prognostic. On the other hand, HR-MRI could be a useful imaging modality to evaluate the characteristics of plaque in stroke patients due to atherosclerosis stenosis, which will help us find out the etiology of stroke 3. Previous studies have demonstrated its prognosis value in predicting recurrent stroke in the same vascular territory 4. The investigators hypothesize that with an appropriate evaluation, HR-MRI could help to predict recurrent stroke in the same vascular territory in patients with high-risk plaque characteristics on HR-MRI. These findings could contribute to individual treatment according to etiology 5,6.
The investigators intend to conduct a study to determine the correlation between plaque characteristics and recurrent stroke in the same vascular territory in ischemic stroke patients due to middle cerebral artery stenosis
- Conditions
- High Resolution Vessel Wall Imaging, Recurrent Stroke, Stroke, Mechanism, Atheroscleroses, Intracranial, Stroke, Infarct Pattern
- Medical subject headings
- Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCA stroke patient | The investigators would include patients who had ischemic stroke due to middle cerebral artery (MCA) stenosis (>50%). The investigators collect plaque characteristics such as plaque enhancement, T1 hyperintense, remodeling ratio, surface irregularity, correlation with the origin of perforating branches, percent stenosis, upstream angle, and downstream angle. The patients were followed up for stroke recurrence for 6 months. For each culprit-plaque characteristic, the investigators would divide the patients into groups of patients with culprit-plaque characteristics and groups without culprit-plaque characteristics. The two groups will compare the type of ischemic lesions and the recurrent stroke rate in the same vascular territory. These results will be presented by Kaplan-Meier curve and binary logistic regression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI
The investigators will determine the rate of recurrent stroke based on the clinical presentation in combination with the MRI lesion if the patient has symptoms suggestive of recurrent stroke.
Measured: 03/2024-12/2026
Secondary outcomes (2)
Determine the rate of plaque characteristics
The investigators will examine the plaque characteristics of high-resolution MRI, including plaque enhancement, T1 hyperintense, remodeling ratio, surface irregularity, correlation with the origin of perforating branches, upstream angle, and downstream angle
Measured: 03/2024-12/2026
Determine the correlation between plaque characteristics and type of ischemic lesions (stroke mechanism) for each of culprit-plaque characteristics on MRI
The investigators will divide the type of ischemic stroke into Artery-to-Artery Embolic Infarction or non Artery-to-Artery Embolic Infarction (including Occlusion of perforating branches, hypoperfusion, or combination).
Measured: 03/2024-12/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start27 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 High Resolution Vessel Wall 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Duy Khoa, University Medical Center Ho Chi Minh City (UMC)
- Investigators
- Khoa Dao, MD, Principal investigator, University Medical Center Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404242
- Sponsor's protocol ID
- IRB-VN01002
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When there is an appropriate request, the investigators will consider and provide anonymous data
Publications
Bang OY. Considerations When Subtyping Ischemic Stroke in Asian Patients. J Clin Neurol. 2016 Apr;12(2):129-36. doi: 10.3988/jcn.2016.12.2.129. Epub 2016 Jan 28.
PubMed 26833987Wong KS, Caplan LR, Kim JS. Stroke Mechanisms. Front Neurol Neurosci. 2016;40:58-71. doi: 10.1159/000448302. Epub 2016 Dec 2.
PubMed 27960181Song JW, Pavlou A, Xiao J, Kasner SE, Fan Z, Messe SR. Vessel Wall Magnetic Resonance Imaging Biomarkers of Symptomatic Intracranial Atherosclerosis: A Meta-Analysis. Stroke. 2021 Jan;52(1):193-202. doi: 10.1161/STROKEAHA.120.031480. Epub 2020 Dec 2.
PubMed 33370193Wu F, Song H, Ma Q, Xiao J, Jiang T, Huang X, Bi X, Guo X, Li D, Yang Q, Ji X, Fan Z; WISP Investigators. Hyperintense Plaque on Intracranial Vessel Wall Magnetic Resonance Imaging as a Predictor of Artery-to-Artery Embolic Infarction. Stroke. 2018 Apr;49(4):905-911. doi: 10.1161/STROKEAHA.117.020046. Epub 2018 Mar 14.
PubMed 29540606Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
PubMed 29766750Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
PubMed 23803136Kim JM, Jung KH, Sohn CH, Moon J, Shin JH, Park J, Lee SH, Han MH, Roh JK. Intracranial plaque enhancement from high resolution vessel wall magnetic resonance imaging predicts stroke recurrence. Int J Stroke. 2016 Feb;11(2):171-9. doi: 10.1177/1747493015609775.
PubMed 26783308Leung TW, Wang L, Zou X, Soo Y, Pu Y, Ip HL, Chan A, Au LWC, Fan F, Ma SH, Ip B, Ma K, Lau AY, Leung H, Hui KF, Li R, Li SH, Fu M, Fong WC, Liu J, Mok V, Wong KSL, Miao Z, Ma N, Yu SCH, Leng X. Plaque morphology in acute symptomatic intracranial atherosclerotic disease. J Neurol Neurosurg Psychiatry. 2020 Nov 25;92(4):370-6. doi: 10.1136/jnnp-2020-325027. Online ahead of print.
PubMed 33239439
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Characteristics From Vessel Wall Magnetic Resonance Imaging Predict Recurrent Stroke in Ischemic Stroke Patients Due to Middle Cerebral Artery Stenosis
- ClinicalTrials.gov ID
- NCT06404242
- Acronym / sponsor ID
- IRB-VN01002
- Conditions
- High Resolution Vessel Wall Imaging, Recurrent Stroke, Stroke, Mechanism, Atheroscleroses, Intracranial, Stroke, Infarct Pattern
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- 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.
The epidemiology of TOAST classification in Asian patients seems to differ due to the higher rates of large-artery atherosclerosis. The complex pathology of atherosclerosis could lead to recurrent stroke, including shear stress on the endothelium, disturbance of the flow, occlusion at the origin of the perforating artery, and other complications (plaque inflammation, plaque hemorrhage, plaque rupture) that could lead to stroke and recurrent stroke. Therefore, The exact determination of the etiology of stroke due to atherosclerosis is the most critical factor for treatment and prognostic. On the other hand, HR-MRI could be a useful imaging modality to evaluate the characteristics of plaque in stroke patients due to atherosclerosis stenosis, which will help us find out the etiology of stroke. Previous studies have demonstrated its prognosis value in predicting recurrent stroke in the same vascular territory. The investigators hypothesize that with an appropriate evaluation, HR-MRI could help to predict recurrent stroke in the same vascular territory in patients with high-risk plaque characteristics on HR-MRI. These findings could contribute to individual treatment according to etiology.
The investigators intend to conduct a study to determine the correlation between plaque characteristics and recurrent stroke in the same vascular territory in ischemic stroke patients due to middle cerebral artery stenosis.
Detailed description
The epidemiology of TOAST classification in Asian patients seems to differ due to the higher rates of large-artery atherosclerosis 1. The complex pathology of atherosclerosis could lead to recurrent stroke, including shear stress on the endothelium, disturbance of the flow, occlusion at the origin of the perforating artery, and other complications (plaque inflammation, plaque hemorrhage, plaque rupture) that could lead to stroke and recurrent stroke 2. Therefore, The exact determination of the etiology of stroke due to atherosclerosis is the most critical factor for treatment and prognostic. On the other hand, HR-MRI could be a useful imaging modality to evaluate the characteristics of plaque in stroke patients due to atherosclerosis stenosis, which will help us find out the etiology of stroke 3. Previous studies have demonstrated its prognosis value in predicting recurrent stroke in the same vascular territory 4. The investigators hypothesize that with an appropriate evaluation, HR-MRI could help to predict recurrent stroke in the same vascular territory in patients with high-risk plaque characteristics on HR-MRI. These findings could contribute to individual treatment according to etiology 5,6.
The investigators intend to conduct a study to determine the correlation between plaque characteristics and recurrent stroke in the same vascular territory in ischemic stroke patients due to middle cerebral artery stenosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCA stroke patient | – | –The investigators would include patients who had ischemic stroke due to middle cerebral artery (MCA) stenosis (>50%). The investigators collect plaque characteristics such as plaque enhancement, T1 hyperintense, remodeling ratio, surface irregularity, correlation with the origin of perforating branches, percent stenosis, upstream angle, and downstream angle. The patients were followed up for stroke recurrence for 6 months. For each culprit-plaque characteristic, the investigators would divide the patients into groups of patients with culprit-plaque characteristics and groups without culprit-plaque characteristics. The two groups will compare the type of ischemic lesions and the recurrent stroke rate in the same vascular territory. These results will be presented by Kaplan-Meier curve and binary logistic regression. |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators would include patients who had ischemic stroke due to middle cerebral artery (MCA) stenosis (>50%)
Key inclusion criteria (3 listed)
- Patients who had a first-time ischemic stroke due to MCA atherosclerosis stenosis more than 50% and admitted to our hospital within 7 days after onset.
- Patients are more than 45 years old.
- Patients had HR-MRI and have done the full stroke workup (including carotid duplex scanning, fasting lipid profile, Holter ECG 24 hours, cardiac ultrasound,...)
Key exclusion criteria (6 listed)
- Patients also have stenosis of the carotid artery (more than 50%) or occulsion on the same side of ischemic stroke
- Patients also have an ischemic stroke in territories other than MCA territory.
- Patients had any characteristics that suggested other causes for their stenosis, including moyamoya, dissection, and inflammation on their MRI and HR-MRI.
- Patients with evidence suggestive of cardioembolism (Atrial fibrillation, decreased EF <50%, recent heart attack in 3 weeks, rheumatic valvular heart disease, dilated cardiopathy, sick sinus syndrome, infective endocarditis).
- Any signs suggestive other causes (non atherosclerosis etiology), including autoimmune disease or increased coagulation state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI
Time frame: 03/2024-12/2026
The investigators will determine the rate of recurrent stroke based on the clinical presentation in combination with the MRI lesion if the patient has symptoms suggestive of recurrent stroke.
2 secondary outcomes
Determine the rate of plaque characteristics
Time frame: 03/2024-12/2026
Determine the correlation between plaque characteristics and type of ischemic lesions (stroke mechanism) for each of culprit-plaque characteristics on MRI
Time frame: 03/2024-12/2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 26833987Bang OY. Considerations When Subtyping Ischemic Stroke in Asian Patients. J Clin Neurol. 2016 Apr;12(2):129-36. doi: 10.3988/jcn.2016.12.2.129. Epub 2016 Jan 28.
- Background: PubMed 27960181Wong KS, Caplan LR, Kim JS. Stroke Mechanisms. Front Neurol Neurosci. 2016;40:58-71. doi: 10.1159/000448302. Epub 2016 Dec 2.
- Background: PubMed 33370193Song JW, Pavlou A, Xiao J, Kasner SE, Fan Z, Messe SR. Vessel Wall Magnetic Resonance Imaging Biomarkers of Symptomatic Intracranial Atherosclerosis: A Meta-Analysis. Stroke. 2021 Jan;52(1):193-202. doi: 10.1161/STROKEAHA.120.031480. Epub 2020 Dec 2.
- Background: PubMed 29540606Wu F, Song H, Ma Q, Xiao J, Jiang T, Huang X, Bi X, Guo X, Li D, Yang Q, Ji X, Fan Z; WISP Investigators. Hyperintense Plaque on Intracranial Vessel Wall Magnetic Resonance Imaging as a Predictor of Artery-to-Artery Embolic Infarction. Stroke. 2018 Apr;49(4):905-911. doi: 10.1161/STROKEAHA.117.020046. Epub 2018 Mar 14.
- Background: PubMed 29766750Johnston SC, Easton JD, Farrant M, Barsan W, Conwit RA, Elm JJ, Kim AS, Lindblad AS, Palesch YY; Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators. Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA. N Engl J Med. 2018 Jul 19;379(3):215-225. doi: 10.1056/NEJMoa1800410. Epub 2018 May 16.
- Background: PubMed 23803136Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.
- Background: PubMed 26783308Kim JM, Jung KH, Sohn CH, Moon J, Shin JH, Park J, Lee SH, Han MH, Roh JK. Intracranial plaque enhancement from high resolution vessel wall magnetic resonance imaging predicts stroke recurrence. Int J Stroke. 2016 Feb;11(2):171-9. doi: 10.1177/1747493015609775.
- Background: PubMed 33239439Leung TW, Wang L, Zou X, Soo Y, Pu Y, Ip HL, Chan A, Au LWC, Fan F, Ma SH, Ip B, Ma K, Lau AY, Leung H, Hui KF, Li R, Li SH, Fu M, Fong WC, Liu J, Mok V, Wong KSL, Miao Z, Ma N, Yu SCH, Leng X. Plaque morphology in acute symptomatic intracranial atherosclerotic disease. J Neurol Neurosurg Psychiatry. 2020 Nov 25;92(4):370-6. doi: 10.1136/jnnp-2020-325027. Online ahead of print.
- Individual participant dataSharing planned: Yes. When there is an appropriate request, the investigators will consider and provide anonymous data
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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.
Khoa Dao, MD principal investigator
University Medical Center Ho Chi Minh City
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 High Resolution Vessel Wall Imaging and Recurrent Stroke, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
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 6 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khoa Dao, MD (+84986883254, khoa.dd@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI (time frame: 03/2024-12/2026). 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 NCT06404242, 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 6 Aug 2026.