Carotid Artery StenosisNCT00451529
Predictive Value for Stroke
An observational study of Carotid Artery Stenosis, run by Dutch Heart Foundation at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Stenosis
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2007to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Hospital Maastricht, Department of Radiology
Maastricht, Limburg, 6202 AZ
Marianne E Kooi, PhD, +31-(0)43-3876910, eline.kooi@mumc.nl
About this study
Official title: Predictive Value of Magnetic Resonance Imaging (MRI), 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and Microemboli Detection for Stroke
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
- Medical subject headings
- Carotid Stenosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startAug 2007
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dutch Heart Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht
- Investigators
- Marianne E Kooi, PhD, Principal investigator, University Hospital Maastricht, Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451529
- Sponsor's protocol ID
- 2006 B0
- Status last verified
- Apr 2011
- First submitted
- 22 Mar 2007
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24114456
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Magnetic Resonance Imaging (MRI), 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and Microemboli Detection for Stroke
- ClinicalTrials.gov ID
- NCT00451529
- Acronym / sponsor ID
- 2006 B0
- Conditions
- Carotid Artery Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dutch Heart FoundationUniversity, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht
- Study start
- Aug 2007
- Study completion
- Sep 2011 (estimated)
- First posted
- 23 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Derived from this study: PubMed 24114456Truijman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne E Kooi, PhD principal investigator
University Hospital Maastricht, Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Dutch Heart Foundation at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne E Kooi, PhD (+31-(0)43-3876910, eline.kooi@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011; AzTrials last refreshed its copy on 26 Oct 2026.