Predictive Value for Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Dutch Heart Foundation.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Academisch Ziekenhuis Maastricht
Information provided by:
Dutch Heart Foundation
ClinicalTrials.gov Identifier:
NCT00451529
First received: March 22, 2007
Last updated: April 18, 2011
Last verified: April 2011
  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

Study Type: Observational
Study Design: 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

Further study details as provided by Dutch Heart Foundation:

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided by Dutch Heart Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. M.E. Kooi
ClinicalTrials.gov Identifier: NCT00451529     History of Changes
Other Study ID Numbers: 2006 B0
Study First Received: March 22, 2007
Last Updated: April 18, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on October 23, 2014