About this trial
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.
Eligibility criteria
Qualifiers
Mentally competent
18 years or older
Recent (<30 days) stroke (modified Rankin scale ≤3) or TIA
Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria
Disqualifiers
Cardiac source of embolism
Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy.
MRI contra-indications
Pregnancy
Trial design
Treatments tested in this trial
- IMPROVE Risk Model
Treatment groups
Sponsors and collaborators
Maastricht University Medical Center
Lead sponsor
Academisch Ziekenhuis Maastricht
Collaborator
Amsterdam UMC
Collaborator
UMC Utrecht
Collaborator
Haaglanden Medical Centre
Collaborator
Isala
Collaborator
Radboud University Medical Center
Collaborator
Zuyderland Medical Centre
Collaborator
Albert Schweitzer Hospital
Collaborator
Rijnstate Hospital
Collaborator
Erasmus Medical Center
Collaborator