ParisK: Correlation of Imaging Techniques With Histology (ParisK)

The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology

The possibility to identify the risk of rupture of a carotid plaque will have tremendous impact in clinical decision making. A vulnerable plaque is considered to have a large lipid rich necrotic core (LRNC), a thin fibrous cap, the presence of inflammatory cells, intraplaque haemorrhage and/or neovascularisation (vasa vasorum). The investigators aim to validate imaging of plaque vulnerability with histology. Previous studies have evaluated the use of imaging to assess carotid plaque vulnerability, mostly showing a good correlation between imaging and histology and/or clinical characteristics. However, they have focused on single modalities, (magnetic resonance imaging [MRI], multidetector-row computed tomography (MDCT), ultrasonography (US) or transcranial Doppler (TCD), and have used relatively small cohorts

The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 3.0 Tesla dynamic contrast-enhanced MRI and histology. Moreover, the investigators aim to investigate the correlation between the volume of the LRNC as determined by dual-energy CT and histology.

Secondly, the investigators will investigate the correlation between the volume of the LRNC, the fibrous cap status and the volume of the calcifications determined by MRI versus histology, the correlation between number of microembolisms and fibrous cap status and the correlation between the deformation pattern seen with ultrasound and the volume of the LRNC.

The imaging parameters showing good correlation with plaque vulnerability characteristics can be used for further analysis in assessing the vulnerable plaque

Study Overview

• Status: Completed
• Conditions: Stroke; Plaque, Atherosclerotic
• Intervention / Treatment: Other: Ultrasound; Other: Magnetic Resonance Imaging (MRI); Radiation: Dual-Energy Computed Tomography (DECT); Other: Transcranial doppler

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands
      • Maastricht University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.

Description

Inclusion Criteria:

• Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy
• Age 18 years or older (no maximum age)
• Informed consent by signing informed consent form regarding this study

• Inclusion criteria for carotid endarterectomy

  1. Symptomatic carotid artery stenosis 70-99% within 3 months of neurological symptoms
  2. Symptomatic carotid artery stenosis 50-99% in man within 2 weeks of neurological symptoms
  3. Asymptomatic carotid artery stenosis 70-99% with contralateral occlusion

Exclusion Criteria:

• Severe co-morbidity, dementia or pregnancy
• Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc.)
• Patients who have a documented allergy to MRI or CT contrast media
• Patients with a renal clearance <30 ml/min are not eligible to undergo contrast-enhanced MRI
• Patients with a renal clearance <60 ml/min are not eligible to undergo CT
• Surgery planned within 4 days of inclusion

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients scheduled for CEA; All patients who are scheduled for carotid endarterectomy (CEA)	Other: Ultrasound; Other Names: Philips IU22; Other: Magnetic Resonance Imaging (MRI); Multi-sequence MR protocol; Other Names: 3.0 T Philips Achieva; Radiation: Dual-Energy Computed Tomography (DECT); Other Names: Siemens Flash; Other: Transcranial doppler; Other Names: Hemodynamics AG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ktrans on dynamic contrast-enhanced (DCE)-MRI	The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.	1 day
Lipid-rich necrotic core on dual-energy CT	The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
deformation pattern on ultrasound	The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.	1 day
number of recorded micro embolic signals (MES)	The relation between number of recorded MES and fibrous cap status at histology.	1 day
Volume of LRNC and calcifications and fibrous cap status on MRI	The correlation between volume of LRNC, fibrous cap status and volume of calcifications in carotid atherosclerotic plaques visualised by MRI and the same features as determined at histology.	1 day

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Dutch Heart Foundation; Center for Translational Molecular Medicine
• Investigators: Study Chair: Eline Kooi, PhD, Maastricht University Medical Center

Publications and helpful links

General Publications

• 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.
• Truijman MT, de Rotte AA, Aaslid R, van Dijk AC, Steinbuch J, Liem MI, Schreuder FH, van der Steen AF, Daemen MJ, van Oostenbrugge RJ, Wildberger JE, Nederkoorn PJ, Hendrikse J, van der Lugt A, Kooi ME, Mess WH; Plaque at RISK Study. Intraplaque hemorrhage, fibrous cap status, and microembolic signals in symptomatic patients with mild to moderate carotid artery stenosis: the Plaque at RISK study. Stroke. 2014 Nov;45(11):3423-6. doi: 10.1161/STROKEAHA.114.006800. Epub 2014 Sep 25.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimated): October 17, 2012

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Carotid Arteries; Endarterectomy, Carotid
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Plaque, Atherosclerotic
• Other Study ID Numbers: 10-2-048