ParisK: Validation of Imaging Techniques (ParisK)
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|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|
|Actual Primary Completion Date :||December 2016|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|