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临床试验/NCT06404242
NCT06404242招募中不适用

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

University Medical Center Ho Chi Minh City (UMC)1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
1
主要终点
The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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,...)

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI

时间窗: 04/2024-02/2026

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.

The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI

时间窗: 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.

次要结局

  • 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)
  • Determine the rate of plaque characteristics(04/2024-02/2026)
  • Determine the rate of plaque characteristics(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(03/2024-12/2026)

研究者

发起方
University Medical Center Ho Chi Minh City (UMC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dao Duy Khoa

Principal Investigator

University Medical Center Ho Chi Minh City (UMC)

研究点 (1)

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