ParisK: Correlation of Imaging Techniques With Histology

NCT01709045 | Completed

• 1 other identifier: 10-2-048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Plaque, Atherosclerotic

Keywords

Endarterectomy, Carotid; Carotid Arteries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• deformation pattern on ultrasound

  1 day

• number of recorded micro embolic signals (MES)

  1 day

• Volume of LRNC and calcifications and fibrous cap status on MRI

  1 day

Study Arms (1)

Patients scheduled for CEA

All patients who are scheduled for carotid endarterectomy (CEA)

Other: Magnetic Resonance Imaging (MRI); Radiation: Dual-Energy Computed Tomography (DECT); Other: Ultrasound; Other: Transcranial doppler

Interventions

Magnetic Resonance Imaging (MRI) OTHER

Multi-sequence MR protocol

Also known as: 3.0 T Philips Achieva

Patients scheduled for CEA

Dual-Energy Computed Tomography (DECT) RADIATION

Also known as: Siemens Flash

Patients scheduled for CEA

Ultrasound OTHER

Also known as: Philips IU22

Patients scheduled for CEA

Transcranial doppler OTHER

Also known as: Hemodynamics AG

Patients scheduled for CEA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Center for Translational Molecular Medicine: collaborator
• Dutch Heart Foundation: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 39836610 DERIVED

• 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.

  PMID: 30832656 DERIVED

• 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.

  PMID: 25256179 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Carotid plaque removed during carotid endarterectomy

MeSH Terms

Conditions

Stroke; Plaque, Atherosclerotic

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological

Study Officials

• Eline Kooi, PhD

  Maastricht University Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

NL (1)