ParisK: Validation of Imaging Techniques (ParisK)
|ClinicalTrials.gov Identifier: NCT01208025|
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : September 6, 2017
The possibility of the identification of the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69% stenosis, who are currently not operated upon according to the current guidelines, identification of the risk of rupture plaque could identify patients who have a high risk of recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent placement. This could potentially prevent a substantial number of strokes. Secondly, in all symptomatic patients with a 70-99% stenosis carotid intervention should be considered, according to the guidelines. However, only one out of six patients with a 70-99% stenosis benefits from a carotid intervention. Identification of patients with a high risk of a recurrent stroke would reduce the number of unnecessary interventions substantially.
The main objective is to show whether imaging characteristics assessed at baseline can predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.
|Condition or disease||Intervention/treatment|
|Stroke Atherosclerosis||Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)|
|Study Type :||Observational|
|Actual Enrollment :||244 participants|
|Official Title:||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.|
|Study Start Date :||September 2010|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
symptomatic carotid stenosis 30-69%
Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30% and 69% according to the European Carotid Surgery Trial (ECST) criteria.
Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
3 Tesla Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
- stroke [ Time Frame: within 5 years of follow-up ]Ipsilateral recurrent ischemic stroke, transient ischaemic attack (TIA) or new ischemic brain lesions on follow-up brain MRI.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01208025
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands|
|Academic Medical Center|
|Amsterdam, Noord-Holland, Netherlands|
|Erasmus Medical Center|
|Rotterdam, Zuid-Holland, Netherlands|
|University Medical Center Utrecht|
|Principal Investigator:||Eline Kooi, PhD||Maastricht University Medical Center|