Clinical trial NCT01709045: ParisK: Correlation of Imaging Techniques With Histology
Official title: The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Plaque, Atherosclerotic
Keywords: Endarterectomy, Carotid
Carotid Arteries
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Translational Molecular Medicine
name: Dutch Heart Foundation
First posted: 2012-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.

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


Eligibility criteria: 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

Primary outcomes:
measure: Ktrans on dynamic contrast-enhanced (DCE)-MRI
timeFrame: 1 day
measure: Lipid-rich necrotic core on dual-energy CT
timeFrame: 1 day
Secondary outcomes:
measure: deformation pattern on ultrasound
timeFrame: 1 day
measure: number of recorded micro embolic signals (MES)
timeFrame: 1 day
measure: Volume of LRNC and calcifications and fibrous cap status on MRI
timeFrame: 1 day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Eline Kooi, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.