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Predictive Value for Stroke
This study is currently recruiting participants.
Verified by Dutch Heart Foundation, November 2008
Sponsors and Collaborators: Dutch Heart Foundation
Academisch Ziekenhuis Maastricht
Information provided by: Dutch Heart Foundation
ClinicalTrials.gov Identifier: NCT00451529
  Purpose

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
Carotid Artery Stenosis

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Predictive Value of Magnetic Resonance Imaging (MRI), 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and Microemboli Detection for Stroke

Further study details as provided by Dutch Heart Foundation:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: April 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451529

Contacts
Contact: Marianne E Kooi, PhD +31-(0)43-3876910 eline.kooi@mumc.nl

Locations
Netherlands, Limburg
University Hospital Maastricht, Department of Radiology Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Marianne E Kooi, PhD     +31-(0)43-3876910     eline.kooi@mumc.nl    
Sponsors and Collaborators
Dutch Heart Foundation
Academisch Ziekenhuis Maastricht
Investigators
Principal Investigator: Marianne E Kooi, PhD University Hospital Maastricht, Department of Radiology
  More Information

Responsible Party: Dr. M.E. Kooi ( Dr. M.E. Kooi )
Study ID Numbers: 2006 B0
Study First Received: March 22, 2007
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00451529  
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:
Arterial Occlusive Diseases
Carotid Stenosis
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Constriction, Pathologic
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009