Predictive Value for Stroke

NCT00451529 | Unknown DMC

• 1 other identifier: 2006 B0
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Carotid Artery Stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of transient ischemic attack or minor stroke within three months of enrollment and an ipsilateral 30-69% carotid stenosis.

You may qualify if:

• 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

You may not qualify if:

• 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 prior TIA or stroke

Sponsors & Collaborators

• Dutch Heart Foundation: lead
• Academisch Ziekenhuis Maastricht: collaborator

Study Sites (1)

University Hospital Maastricht, Department of Radiology

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

Related Publications (1)

• Truijman MT, Kwee RM, van Hoof RH, Hermeling E, van Oostenbrugge RJ, Mess WH, Backes WH, Daemen MJ, Bucerius J, Wildberger JE, Kooi ME. Combined 18F-FDG PET-CT and DCE-MRI to assess inflammation and microvascularization in atherosclerotic plaques. Stroke. 2013 Dec;44(12):3568-70. doi: 10.1161/STROKEAHA.113.003140. Epub 2013 Oct 10.

  PMID: 24114456 DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marianne E Kooi, PhD

  University Hospital Maastricht, Department of Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne E Kooi, PhD

CONTACT

+31-(0)43-3876910; eline.kooi@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: August 1, 2007
• Study Completion: September 1, 2011
• Last Updated: April 19, 2011

Record last verified: 2011-04

Locations

NL (1)