Clinical Impact of the Use of IMPROVE for Selection of Patients for Carotid Revascularisation: a Randomized Controlled Trial in Symptomatic Patients With 30-99% Carotid Stenosis

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.

Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation