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StrokeParisKNCT01208025

ParisK: Validation of Imaging Techniques

An observational study of Stroke and Atherosclerosis, run by Maastricht University Medical Center at 4 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Atherosclerosis
What is being tested?
Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
How many people
244 participants
Where
4 sitesNetherlands
Study dates
Sep 2010to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Academic Medical Center

    Amsterdam, North Holland

  • Maastricht University Medical Center

    Maastricht, Limburg

  • Erasmus Medical Center

    Rotterdam, South Holland

  • University Medical Center Utrecht

    Utrecht

Other trials in Netherlands

About this study

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.

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.

Being tested
Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
Keywords
Plaque, Imaging
Medical subject headings
Stroke, Atherosclerosis, Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)Other

    3 Tesla Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)

Study groups in NCT01208025
Study groupRoleWhat they receive
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.
Receives: Other: Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. stroke

    Ipsilateral recurrent ischemic stroke, transient ischaemic attack (TIA) or new ischemic brain lesions on follow-up brain MRI.

    Measured: within 5 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01208025
Sponsor's protocol ID
09-2-082
Acronym
ParisK
Status last verified
Sep 2016
First submitted
21 Sep 2010
Last updated
6 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Tziotziou A, Liu Y, Fontana F, Bierens J, Nederkoorn PJ, de Jong PA, Kooi ME, Mess W, van der Lugt A, van der Steen AFW, Bos D, Wentzel JJ, Akyildiz AC. Pressure- and flow-driven biomechanical factors associate with carotid atherosclerosis assessed by computed tomography angiography. Atherosclerosis. 2025 Sep;408:120415. doi: 10.1016/j.atherosclerosis.2025.120415. Epub 2025 Jun 26.

    PubMed 40617722

  • Kassem M, Gorissen T, Albenwan M, Bierens J, van Dam-Nolen DHK, Liem MI, Hofman PAM, Wildberger JE, Hendrikse J, Mess W, Nederkoorn PJ, Bos D, Nelemans P, van Oostenbrugge RJ, Kooi ME. The relationship between fibrous cap status or plaque surface morphology and intraplaque hemorrhage volume over time: The PARISK Study. J Stroke Cerebrovasc Dis. 2025 May;34(5):108283. doi: 10.1016/j.jstrokecerebrovasdis.2025.108283. Epub 2025 Mar 12.

    PubMed 40081118

  • Aizaz M, Bierens J, Gijbels MJJ, Schreuder THCML, van Orshoven NP, Daemen JHC, Mess WH, Flohr T, van Oostenbrugge RJ, Postma AA, Kooi ME. Differentiation of Atherosclerotic Carotid Plaque Components With Dual-Energy Computed Tomography. Invest Radiol. 2025 Aug 1;60(8):508-516. doi: 10.1097/RLI.0000000000001153. Epub 2025 Jan 22.

    PubMed 39836610

  • Nies KPH, Aizaz M, van Dam-Nolen DHK, Goring TCD, Schreuder TAHCML, van Orshoven NP, Postma AA, Bos D, Hendrikse J, Nederkoorn P, van der Geest R, van Oostenbrugge RJ, Mess WH, Kooi ME. Signal intensity and volume of carotid intraplaque hemorrhage on magnetic resonance imaging and the risk of ipsilateral cerebrovascular events: The Plaque At RISK (PARISK) study. J Cardiovasc Magn Reson. 2024 Winter;26(2):101049. doi: 10.1016/j.jocmr.2024.101049. Epub 2024 Jun 13.

    PubMed 38878969

  • van Dam-Nolen DHK, Truijman MTB, van der Kolk AG, Liem MI, Schreuder FHBM, Boersma E, Daemen MJAP, Mess WH, van Oostenbrugge RJ, van der Steen AFW, Bos D, Koudstaal PJ, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME; PARISK Study Group. Carotid Plaque Characteristics Predict Recurrent Ischemic Stroke and TIA: The PARISK (Plaque At RISK) Study. JACC Cardiovasc Imaging. 2022 Oct;15(10):1715-1726. doi: 10.1016/j.jcmg.2022.04.003. Epub 2022 Jun 15.

    PubMed 36202450

  • van Dam-Nolen DHK, van Egmond NCM, Dilba K, Nies K, van der Kolk AG, Liem MI, Kooi ME, Hendrikse J, Nederkoorn PJ, Koudstaal PJ, van der Lugt A, Bos D. Sex Differences in Plaque Composition and Morphology Among Symptomatic Patients With Mild-to-Moderate Carotid Artery Stenosis. Stroke. 2022 Feb;53(2):370-378. doi: 10.1161/STROKEAHA.121.036564. Epub 2022 Jan 5.

    PubMed 34983237

  • Crombag GAJC, van Hoof RHM, Holtackers RJ, Schreuder FHBM, Truijman MTB, Schreuder TAHCML, van Orshoven NP, Mess WH, Hofman PAM, van Oostenbrugge RJ, Wildberger JE, Kooi ME. Symptomatic Carotid Plaques Demonstrate Less Leaky Plaque Microvasculature Compared With the Contralateral Side: A Dynamic Contrast-Enhanced Magnetic Resonance Imaging Study. J Am Heart Assoc. 2019 Apr 16;8(8):e011832. doi: 10.1161/JAHA.118.011832.

    PubMed 30971168

  • van Dijk AC, Donkel SJ, Zadi T, Sonneveld MAH, Schreuder FHBM, Chohan MF, Koudstaal PJ, Leebeek FWG, Saxena R, Hendrikse J, Kooi ME, van der Lugt A, de Maat MPM. Association between fibrinogen and fibrinogen gamma' and atherosclerotic plaque morphology and composition in symptomatic carotid artery stenosis: Plaque-At-RISK study. Thromb Res. 2019 May;177:130-135. doi: 10.1016/j.thromres.2019.02.030. Epub 2019 Feb 27.

    PubMed 30897531

  • Crombag GAJC, Schreuder FHBM, van Hoof RHM, Truijman MTB, Wijnen NJA, Voo SA, Nelemans PJ, Heeneman S, Nederkoorn PJ, Daemen JH, Daemen MJAP, Mess WH, Wildberger JE, van Oostenbrugge RJ, Kooi ME. Microvasculature and intraplaque hemorrhage in atherosclerotic carotid lesions: a cardiovascular magnetic resonance imaging study. J Cardiovasc Magn Reson. 2019 Mar 4;21(1):15. doi: 10.1186/s12968-019-0524-9.

    PubMed 30832656

  • 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.

    PubMed 28376791

  • 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.

    PubMed 25563640

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Atherosclerosis, run by Maastricht University Medical Center at 4 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

stroke (time frame: within 5 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01208025, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.

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ParisK: Validation of Imaging Techniques (NCT01208025) | AzTrials