Predictive Value for Stroke

Carotid Artery Stenosis Clinical Trial

Official title:

Predictive Value of Magnetic Resonance Imaging (MRI), 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and Microemboli Detection for Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00451529
• Other study ID #: 2006 B0
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2007
• Last updated: April 18, 2011
• Start date: August 2007
• Est. completion date: September 2011

Study information

• Verified date: April 2011
• Source: Dutch Heart Foundation
• Contact: Marianne E Kooi, PhD
• Phone: +31-(0)43-3876910
• Email: eline.kooi[@]mumc.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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 symptomatic patients with a carotid artery stenosis of 70-99% is highly beneficial. However, the beneficial effect of surgery in patients with symptomatic 30-69% stenosis is not clear yet.A clear beneficial effect of surgery in the 30-69% stenosis group might be found in a sub-group of patients whom are at greater risk for stroke. Definition of this sub-group might be achieved by plaque characterization, since rupture of a vulnerable plaque is the main cause of stroke due to carotid artery stenosis.This study will include patients with a 30-69% carotid artery stenosis, and assess plaque composition by MRI, the degree of plaque inflammation by FDG-PET, and the amount of microembolization by transcranial Doppler ultrasound. The main purpose of this study is to assess whether one or a combination of each of these imaging methods can predict the occurrence of a (recurrent) ischemic stroke.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 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, 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht, Department of Radiology	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Dutch Heart Foundation	Academisch Ziekenhuis Maastricht

Country where clinical trial is conducted

Netherlands,