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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
History of Changes
  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:

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.
Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (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
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

Contacts
Contact: Martine Truijman +31 43 3882599 martine.truijman@mumc.nl

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Eline Kooi, PhD       eline.kooi@mumc.nl   
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: Paul Nederkoorn, MD, PhD       p.j.nederkoorn@amc.uva.nl   
Erasmus Medical Center Recruiting
Rotterdam, Zuid-Holland, Netherlands
Contact: Aad vd Lugt, Prof. dr.       a.vanderlugt@erasmusmc.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Jeroen Hendrikse, MD, PhD       j.hendrikse@umcutrecht.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Eline Kooi, PhD Maastricht University Medical Center
  More Information

No publications provided

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: June 17, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Plaque
Imaging

ClinicalTrials.gov processed this record on March 02, 2015