ParisK: Validation of Imaging Techniques (ParisK)
This study is ongoing, but not recruiting participants.
Sponsor:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01208025
First received: September 21, 2010
Last updated: September 29, 2016
Last verified: September 2016
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Purpose
The possibility of the identification of the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. Firstly, in symptomatic patients with a 30-69% stenosis, who are currently not operated upon according to the current guidelines, identification of the risk of rupture plaque could identify patients who have a high risk of recurrent stroke, and would benefit of carotid intervention, such as endarterectomy or stent placement. This could potentially prevent a substantial number of strokes. Secondly, in all symptomatic patients with a 70-99% stenosis carotid intervention should be considered, according to the guidelines. However, only one out of six patients with a 70-99% stenosis benefits from a carotid intervention. Identification of patients with a high risk of a recurrent stroke would reduce the number of unnecessary interventions substantially.
The main objective is to show whether imaging characteristics assessed at baseline can predict clinical events in patients with a 30-69 % symptomatic carotid stenosis.
| Condition | Intervention |
|---|---|
|
Stroke Atherosclerosis |
Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Prospective Clinical Study for Diagnosis Efficacy for High Risk Plaque and Stroke. |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- stroke [ Time Frame: within 5 years of follow-up ]Ipsilateral recurrent ischemic stroke, transient ischaemic attack (TIA) or new ischemic brain lesions on follow-up brain MRI.
| Enrollment: | 244 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
symptomatic carotid stenosis 30-69%
Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30% and 69% according to the European Carotid Surgery Trial (ECST) criteria.
|
Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
3 Tesla Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with neurological symptoms due to ischemia in the carotid artery territory and with a carotid stenosis between 30-69% according to the ECST criteria will be included.
Criteria
Inclusion Criteria:
- neurological symptoms due to ischemia in the carotid artery territory as diagnosed by their neurologist based on anamneses, physical examination and brain imaging (CT or MRI)
- carotid artery stenosis < 70% (upper cut-off value is based on the NASCET criteria, the lower cut-off value is an atherosclerotic plaque with a thickness of at least 2-3 mm, which corresponds to an ECST stenosis of 30%
- written informed consent
Exclusion Criteria:
- patients with 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
- patients who have a documented allergy to MRI or CT contrast media
- patients with renal clearance < 30 ml/minute are not eligible to undergo contrast-enhanced MRI
- patients with renal clearance < 60 ml/minute are not eligible to undergo MDCT
- patients who had a TIA or minor stroke more than 3 months before inclusion
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01208025
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208025
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Limburg, Netherlands | |
| Academic Medical Center | |
| Amsterdam, Noord-Holland, Netherlands | |
| Erasmus Medical Center | |
| Rotterdam, Zuid-Holland, Netherlands | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands | |
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
| Principal Investigator: | Eline Kooi, PhD | Maastricht University Medical Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01208025 History of Changes |
| Other Study ID Numbers: |
09-2-082 |
| Study First Received: | September 21, 2010 |
| Last Updated: | September 29, 2016 |
Keywords provided by Maastricht University Medical Center:
|
Plaque Imaging |
Additional relevant MeSH terms:
|
Stroke Atherosclerosis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 24, 2017