Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

NCT06404242 | Recruiting

• 1 other identifier: IRB-VN01002
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke, Ischemic; Atherosclerosis, Cerebral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determine the rate of plaque characteristics

  04/2024-02/2026

• Determine the correlation between plaque characteristics and type of ischemic lesions (stroke mechanism) for each of culprit-plaque characteristics on MRI

  04/2024-02/2026

Study Arms (1)

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.

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators would include patients who had ischemic stroke due to middle cerebral artery (MCA) stenosis (\>50%)

You may qualify if:

• 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,...)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Ho Chi Minh City (UMC): lead

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

RECRUITING

Related 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.

  PMID: 26833987 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Khoa Dao, MD

  University Medical Center Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khoa Dao, MD

CONTACT

+84986883254; khoa.dd@umc.edu.vn

Khang Nguyen, MD

CONTACT

+84787415562; khang.nv@umc.edu.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 8, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The data will be available after the study has finished for at least 1 year and will be available for 3 years
• Access Criteria: Upon reasonable request

Locations

VN (1)