Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

Summary

Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs.

Patients will be followed for several years to compare which method is better for health and costs.

Conditions

• Carotid Artery Stenosis Symptomatic
• Ischemic Cerebral Infarction
• Stroke Ischemic
• Atheroscleroses
• Stroke (CVA) or TIA
• Stroke
• Intraplaque Hemorrhage
• TIA (Transient Ischemic Attack)
• Atherosclerosis Cerebral Infarction
• Carotid Arteriosclerosis

Interventions

OTHER

IMPROVE Risk Model

All patients are screened in routine care for stenosis. The stroke risk is assessed using IMPROVE, incorporating plaque vulnerability (intraplaque haemorrhage (IPH) on MRI), stenosis degree, ischemic event type (ocular vs. cerebral), age and sex. The practitioner and patient discuss treatment options in shared decision making based on this risk score. Patients above the risk threshold (≥10% ipsilateral stroke risk within 3 years) receive a recommendation for revascularisation, those below an advice for OMT-only. The 10% threshold resulted in the largest stroke reduction in the decision analytic study. \~53% of the patients need an extra MRI. In \~47% an MRI is unnecessary since, based on the other risk factors, the stroke risk is already high or low and the MRI result does not affect the risk category.

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Haaglanden Medical Centre

  collaborator OTHER

• Isala

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Zuyderland Medical Centre

  collaborator OTHER

• Albert Schweitzer Hospital

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• M. Eline Kooi, Prof. dr. · Maastricht University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-08-31

Completion

2031-08-31

Countries

• Netherlands

Study Locations