Predictive Value for Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451529
Recruitment Status : Unknown
Verified April 2011 by Dutch Heart Foundation.
Recruitment status was:  Recruiting
First Posted : March 23, 2007
Last Update Posted : April 19, 2011
Academisch Ziekenhuis Maastricht
Information provided by:
Dutch Heart Foundation

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.

Condition or disease
Carotid Artery Stenosis

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of Magnetic Resonance Imaging (MRI), 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and Microemboli Detection for Stroke
Study Start Date : August 2007
Estimated Study Completion Date : September 2011

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00451529

Contact: Marianne E Kooi, PhD +31-(0)43-3876910

University Hospital Maastricht, Department of Radiology Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Marianne E Kooi, PhD    +31-(0)43-3876910   
Sponsors and Collaborators
Dutch Heart Foundation
Academisch Ziekenhuis Maastricht
Principal Investigator: Marianne E Kooi, PhD University Hospital Maastricht, Department of Radiology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. M.E. Kooi Identifier: NCT00451529     History of Changes
Other Study ID Numbers: 2006 B0
First Posted: March 23, 2007    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases