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Completed

NCT Number: NCT01709045

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

magnetic resonance imaging (MRI)

Other

Multi-sequence MR protocol

Other names: 3.0 T Philips Achieva

Dual-Energy Computed Tomography (DECT)

Radiation

Other names: Siemens Flash

ultrasound

Other

Other names: Philips IU22

Transcranial doppler

Other

Other names: Hemodynamics AG

Primary outcomes

  1. Ktrans on dynamic contrast-enhanced (DCE)-MRI

    Time frame: 1 day

    The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.

  2. Lipid-rich necrotic core on dual-energy CT

    Time frame: 1 day

    The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.

Secondary outcomes

  1. deformation pattern on ultrasound

    Time frame: 1 day

    The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.

  2. number of recorded micro embolic signals (MES)

    Time frame: 1 day

    The relation between number of recorded MES and fibrous cap status at histology.

  3. Volume of LRNC and calcifications and fibrous cap status on MRI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Center for Translational Molecular Medicine
  • Dutch Heart Foundation

Registry information

Official study title

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

Acronym: ParisK

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2012
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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