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.

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. - ParisK

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43700

Enrollment

244

Registered

2009-12-07

Start date

2010-05-20

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerotische plaques hardening of the arteries

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Countries

Netherlands

Outcome results