Plaque Characteristics Predict Recurrent Stroke in MCA Stroke Patients

May 4, 2024 updated by: Dao Duy Khoa, University Medical Center Ho Chi Minh City (UMC)

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

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • University Medical Center Ho Chi Minh City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of recurrent stroke at the same vascular territory for each culprit-plaque characteristic on HR-MRI
Time Frame: 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.
04/2024-02/2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the rate of plaque characteristics
Time Frame: 04/2024-02/2026
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
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
Time Frame: 04/2024-02/2026
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).
04/2024-02/2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Ho Chi Minh City (UMC)

Investigators

  • Principal Investigator: Khoa Dao, MD, University Medical Center Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 4, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-VN01002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When there is an appropriate request, the investigators will consider and provide anonymous data

IPD Sharing Time Frame

The data will be available after the study has finished for at least 1 year and will be available for 3 years

IPD Sharing Access Criteria

Upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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