ParisK: Validation of Imaging Techniques - Full Text View

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:

MedlinePlus related topics: Diagnostic Imaging

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

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.


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)
Genders Eligible for Study:	Both
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

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: 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):

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
Study First Received:	September 21, 2010
Last Updated:	May 26, 2015
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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 September 23, 2016

ParisK: Validation of Imaging Techniques (ParisK)