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Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation

RecruitingNAAges 18 Years - anyAllMaastricht University Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Mentally competent * 18 years or older * Recent (\<30 days) stroke (modified Rankin scale โ‰ค3) or TIA * Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria * Life expectancy \>5 years * Patient and stenosis are suitable for carotid revascularisation * Patient is agreeable to randomisation and willing to accept either IMPROVE-based or CAU-based selection method for carotid revascularisation Exclusion Criteria: * Cardiac source of embolism * Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy. * MRI contra-indications * Pregnancy
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What it tests

  • IMPROVE Risk Model
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Where

10 sites
Rijnstate
Arnhem, Netherlands
Radboud UMC
Nijmegen, Netherlands
Zuyderland
Heerlen, Netherlands
Maastricht University
Maastricht, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Isala
Zwolle, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Erasmus MC
Rotterdam, Netherlands

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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