ParisK: Validation of Imaging Techniques

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01208025
First received: September 21, 2010
Last updated: June 17, 2013
Last verified: June 2013

September 21, 2010
June 17, 2013
September 2010
December 2014   (final data collection date for primary outcome measure)
stroke [ Time Frame: within 5 years of follow-up ] [ Designated as safety issue: No ]
Ipsilateral recurrent ischemic stroke, transient ischaemic attack (TIA) or new ischemic brain lesions on follow-up brain MRI.
stroke [ Time Frame: within 5 years of follow-up ] [ Designated as safety issue: No ]
Ipsilateral recurrent ischemic stroke
Complete list of historical versions of study NCT01208025 on ClinicalTrials.gov Archive Site
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ParisK: Validation of Imaging Techniques
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.

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Stroke
  • Atherosclerosis
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)
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.
Intervention: Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Martine Truijman +31 43 3882599 martine.truijman@mumc.nl
Netherlands
 
NCT01208025
09-2-082
No
Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Eline Kooi, PhD Maastricht University Medical Center
Maastricht University Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP