ParisK: Validation of Imaging Techniques

Stroke Clinical Trial

— ParisK  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208025
• Other study ID #: 09-2-082
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: September 4, 2017
• Start date: September 2010
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Stroke

Intervention

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)

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke	Ipsilateral recurrent ischemic stroke, transient ischaemic attack (TIA) or new ischemic brain lesions on follow-up brain MRI.	within 5 years of follow-up