Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404242
• Other study ID #: IRB-VN01002
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University Medical Center Ho Chi Minh City (UMC)
• Contact: Khoa Dao, MD
• Phone: +84986883254
• Email: khoa.dd[@]umc.edu.vn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: June 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 100 Years

Eligibility

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%) 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 of autoimmune disease or increased coagulation state.

• Patients with severe concomitant disease could affect the 6-month follow-up of the patients.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis, Cerebral
• Intracranial Arteriosclerosis
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Locations

Country	Name	City	State
Vietnam	University Medical Center Ho Chi Minh City	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Ho Chi Minh City (UMC)

Country where clinical trial is conducted

Vietnam, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wong KS, Caplan LR, Kim JS. Stroke Mechanisms. Front Neurol Neurosci. 2016;40:58-71. doi: 10.1159/000448302. Epub 2016 Dec 2. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	04/2024-02/2026
Secondary	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	04/2024-02/2026
Secondary	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).	04/2024-02/2026