Status:
COMPLETED
ParisK: Validation of Imaging Techniques
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Stroke
Atherosclerosis
Eligibility:
All Genders
18+ years
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- neurological symptoms due to ischemia in the carotid artery territory as diagnosed by their neurologist based on anamneses, physical examination and brain imaging (CT or MRI)
- carotid artery stenosis \< 70% (upper cut-off value is based on the NASCET criteria, the lower cut-off value is an atherosclerotic plaque with a thickness of at least 2-3 mm, which corresponds to an ECST stenosis of 30%
- written informed consent
Exclusion
- patients with 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
- patients who have a documented allergy to MRI or CT contrast media
- patients with renal clearance \< 30 ml/minute are not eligible to undergo contrast-enhanced MRI
- patients with renal clearance \< 60 ml/minute are not eligible to undergo MDCT
- patients who had a TIA or minor stroke more than 3 months before inclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT01208025
Start Date
September 1 2010
End Date
December 1 2016
Last Update
September 6 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
2
Academic Medical Center
Amsterdam, North Holland, Netherlands
3
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
4
University Medical Center Utrecht
Utrecht, Netherlands