The assessment of the Plaque At RISK by non-invasive (molecular) imaging and modelling (ParisK): Prospective clinical study for diagnosis efficacy for high risk plaque and stroke.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 244

Inclusion Criteria

-Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30% and 69% according to ECST criteria will be included (n<=244).
-Asymptomatic patients with a carotid stenosis between 30 and 69% according to ECST criteria will be included in the MUMC (n<=20) to study reproducibility 3T MRI.
-Healthy volunteers recruited in the MUMC (n<=15) to optimalize the 3T MRI protocol.

Exclusion Criteria

- Patients with a probable cardiac source of embolism (rhythm disorders, mitral valve stenosis, prolapse or calcification, mechanical cardiac valves, recent myocardial infarction, left ventricular thrombus, atrial myxoma, endocarditis, dilated cardiomyopathy, patent foramen ovale) or a clotting disorder.
- Patients with evident other cause of neurological symptoms than carotid stenosis due to atherosclerotic disease (like demyelinating diseases, epilepsy, congenital brain disorders, aneurysms, fibromuscular dysplasia, etc.).
- Patients already scheduled for carotid endarterectomy or stenting
- Severe co-morbidity, dementia, or pregnancy.
- Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia etc).
- Patients who have a documented allergy to contrast media are not eligible to undergo contrast-enhanced MRI or contrast-enhanced CT.
- Patients with a renal clearance <30 ml/minute are not eligible to undergo contrast-enhanced MRI. Patients with a renal clearance of <60 ml/minute are not eligible to undergo contrast-enhanced CT.
- Patients who had a TIA or minor stroke more than 3 months before inclusion

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint is recurrent ischemic stroke, or TIA and/or new<br /><br>ipsilateral brain lesions on follow-up brain MRI. For the primary analysis we<br /><br>will assess the following parameters: 1) presence of IPH as assessed on<br /><br>ipsilateral MRI of carotid plaque, 2) ipsilateral carotid plaque ulceration as<br /><br>assessed on MDCTA, 3) ipsilateral carotid plaque volume as assessed on MRI, and<br /><br>4) the proportion of calcifications with respect to the ipsilateral carotid<br /><br>plaque volume as assessed with MDCT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoints:<br /><br><br /><br>- Plaque progression or regression assessed by repeated imaging.<br /><br>- Detection of (new) subclinical vascular brain damage by MRI<br /><br>- Emboli detection assessed by TCD.<br /><br>- In case patients with recurrent events will undergo carotid intervention<br /><br>before the two year follow-up, repeat imaging using MRI, MDCT, US and TCD will<br /><br>be done in those patients before carotid endarterectomy.</p><br>