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Recruiting NCT06404242

Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

— Observational High Resolution Vessel Wall Imaging Recurrent Stroke Stroke, Mechanism Atheroscleroses, Intracranial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: High Resolution Vessel Wall Imaging, Recurrent Stroke, Stroke, Mechanism, Atheroscleroses, Intracranial. Basic parameters: 45 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Plaque Characteristics From Vessel Wall Magnetic Resonance Imaging Predict Recurrent Stroke in Ischemic Stroke Patients Due to Middle Cerebral Artery Stenosis

Overview

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

Primary outcome measures

  • The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI [Time frame: 03/2024-12/2026]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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,...)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Vietnam · 1 center
  • University Medical Center Ho Chi Minh City — Ho Chi Minh City

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. PMID 26833987
  • Wong KS, Caplan LR, Kim JS. Stroke Mechanisms. Front Neurol Neurosci. 2016;40:58-71. doi: 10.1159/000448302. Epub 2016 Dec 2. PMID 27960181
  • Song 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. PMID 33370193
  • Wu 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. PMID 29540606
  • Johnston 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. PMID 29766750
  • Wang 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. PMID 23803136
  • Kim 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. PMID 26783308
  • Leung 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. PMID 33239439

Identifiers

NCT: NCT06404242 · IRB-VN01002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗