ParisK: Validation of Imaging Techniques (ParisK)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Stroke; Atherosclerosis	Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)

Study Design

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Study Type :	Observational
Actual Enrollment :	244 participants
Observational Model:	Other
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.
Study Start Date :	September 2010
Actual Primary Completion Date :	December 2016
Actual Study Completion Date :	December 2016

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Steinbuch J, van Dijk AC, Schreuder F, Truijman M, Hendrikse J, Nederkoorn PJ, van der Lugt A, Hermeling E, Hoeks A, Mess WH. Definition of common carotid wall thickness affects risk classification in relation to degree of internal carotid artery stenosis: the Plaque At RISK (PARISK) study. Cardiovasc Ultrasound. 2017 Apr 4;15(1):9. doi: 10.1186/s12947-017-0097-4.

de Rotte AA, Truijman MT, van Dijk AC, Liem MI, Schreuder FH, van der Kolk AG, de Kruijk JR, Daemen MJ, van der Steen AF, de Borst GJ, Luijten PR, Nederkoorn PJ, Kooi ME, van der Lugt A, Hendrikse J. Plaque components in symptomatic moderately stenosed carotid arteries related to cerebral infarcts: the plaque at RISK study. Stroke. 2015 Feb;46(2):568-71. doi: 10.1161/STROKEAHA.114.008121. Epub 2015 Jan 6.

Responsible Party:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT01208025 History of Changes
Other Study ID Numbers:	09-2-082
First Posted:	September 23, 2010
Last Update Posted:	September 6, 2017
Last Verified:	September 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