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NCT Number: NCT06404242

Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

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.

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Key information

Age range

45 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location status: Recruiting

Location contact

Khoa Dao

CONTACT

[email protected]

+84986883254

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Determine the rate of plaque characteristics

    Time frame: 03/2024-12/2026

    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

  2. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Khang Nguyen, MD

CONTACT

[email protected]

+84787415562

Khoa Dao, MD

CONTACT

[email protected]

+84986883254

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 8, 2024
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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