Status:
UNKNOWN
Predictive Value for Stroke
Lead Sponsor:
Dutch Heart Foundation
Collaborating Sponsors:
Academisch Ziekenhuis Maastricht
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
Patients with a moderate to severe carotid atherosclerotic plaque are at risk for stroke and this risk increases with increasing degree of stenosis. It has been shown that carotid endarterectomy in sy...
Eligibility Criteria
Inclusion
- Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30% and 69% as detected by ultrasound examination
Exclusion
- 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, documented allergy to contrast media, renal insufficiency, etc).
- Patients who were referred from another hospital to one of the three participating hospitals (to avoid referral bias).
- Patients who had a TIA or minor stroke more than 3 weeks before inclusion
- Patients who had a prior TIA or stroke
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00451529
Start Date
August 1 2007
End Date
September 1 2011
Last Update
April 19 2011
Active Locations (1)
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1
University Hospital Maastricht, Department of Radiology
Maastricht, Limburg, Netherlands, 6202 AZ