ParisK: Correlation of Imaging Techniques With Histology

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01709045

Acronym

ParisK

Enrollment

Registered

2012-10-17

Start date

2011-08-31

Completion date

2014-12-31

Last updated

2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque, Atherosclerotic, Stroke

Keywords

Endarterectomy, Carotid, Carotid Arteries

Brief summary

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

Interventions

OTHERMagnetic Resonance Imaging (MRI)

Multi-sequence MR protocol

RADIATIONDual-Energy Computed Tomography (DECT)

OTHERUltrasound

OTHERTranscranial doppler

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
deformation pattern on ultrasound	1 day	The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
number of recorded micro embolic signals (MES)	1 day	The relation between number of recorded MES and fibrous cap status at histology.
Volume of LRNC and calcifications and fibrous cap status on MRI	1 day	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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026