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Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation
Sponsor: Maastricht University Medical Center
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.
Official title: Clinical Impact of the Use of IMPROVE for Selection of Patients for Carotid Revascularisation: a Randomized Controlled Multicentre Non-inferiority Trial in Symptomatic Patients With 30-99% Carotid Stenosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
613
Start Date
2026-03-31
Completion Date
2031-08-31
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (10)
Rijnstate
Arnhem, Gelderland, Netherlands
Radboud UMC
Nijmegen, Gelderland, Netherlands
Zuyderland
Heerlen, Limburg, Netherlands
Maastricht University
Maastricht, Limburg, Netherlands
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
Haaglanden MC
The Hague, South Holland, Netherlands
Utrecht UMC
Utrecht, Utrecht, Netherlands