Evaluating IMPROVE MRI-based Method to Guide Carotid Artery Surgery in Patients with Recent Stroke or TIA and 30-99% Carotid Narrowing
Led by Maastricht University Medical Center · Updated on 2026-05-15
613
Participants Needed
10
Research Sites
156 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to improve treatment decisions for patients with carotid artery disease who have had a recent transient ischemic attack TIA or minor stroke and have narrowing of the carotid artery caused by atherosclerosis. The study evaluates a new MRI-based method called IMPROVE, which detects unstable plaques that increase stroke risk, comparing it to the standard approach that mainly considers how much the artery is narrowed. Researchers hope this new method will better identify patients who need surgery or stenting and reduce strokes while lowering healthcare costs.
Patients will be randomly assigned to either the standard care group or the IMPROVE group. In the IMPROVE group, treatment decisions for carotid revascularisation plus medication and lifestyle advice optimized medical therapy, OMT are guided by the IMPROVE risk score, which incorporates MRI findings and clinical factors to estimate stroke risk. Those with a stroke risk of 10% or higher within three years are recommended for revascularisation plus OMT, while others receive OMT only. The standard care group follows existing guidelines based on the degree of artery narrowing without considering plaque vulnerability.
Participants will be followed for 3 to 5 years, with researchers monitoring for any strokes or death within 44 days after randomisation and ipsilateral ischemic strokes throughout the follow-up. They will also assess quality of life, functional outcomes, hospitalizations, revascularisation procedures, and healthcare costs. Data will be collected through clinical visits, questionnaires, and medical records to evaluate the clinical impact and cost-effectiveness of the IMPROVE method compared to standard care.
CONDITIONS
Brief Title
Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation
Research Team
M
M. Eline Kooi, Prof. dr.
R
Robin M.M. Pleumeekers, MSc.
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Recent stroke or transient ischemic attack (TIA) within 30 days with modified Rankin scale 43
Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation by non-invasive imaging
Life expectancy greater than 5 years
Suitable for carotid revascularisation
Agreeable to randomisation and willing to accept either IMPROVE or standard care selection method
You will not qualify if you...
Cardiac source of embolism
Carotid stenosis caused by non-atherosclerotic disease such as dissection, fibromuscular disease, or neck radiotherapy
Contraindications to MRI
Pregnancy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 30 days
Participants undergo assessment including routine imaging for carotid stenosis and may receive an MRI to evaluate plaque vulnerability and calculate stroke risk using the IMPROVE score.
1 to 2 visits depending on MRI necessity
Treatment
Duration - Until clinical decision and treatment completion
Participants receive treatment based on risk assessment: either carotid revascularisation plus optimized medical therapy (OMT) if high risk, or OMT-only if low risk, with treatment guided by either the IMPROVE score or standard care guidelines.
1 treatment visit plus follow-up visits as needed
Long-term Monitoring
Duration - 3 to 5 years
Participants are monitored for stroke, death, and other cardiovascular events over 3 to 5 years to assess outcomes and quality of life.
Regular follow-up visits throughout monitoring period
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Published Research Related To This Trial
Plaque Magnetic Resonance Imaging Based Decision Rule for the Selection of Symptomatic Patients for Carotid Revascularisation: Clinician Perspectives on Acceptability and Implementation Barriers in the Netherlands.
Juul Bierens, Stephanie M C Ament, Martine T B Truijman...