ParisK: Correlation of Imaging Techniques With Histology (ParisK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01709045
Recruitment Status : Unknown
Verified September 2013 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 17, 2012
Last Update Posted : September 13, 2013
Center for Translational Molecular Medicine
Dutch Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center

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

Condition or disease Intervention/treatment
Stroke Plaque, Atherosclerotic Other: Magnetic Resonance Imaging (MRI) Radiation: Dual-Energy Computed Tomography (DECT) Other: Ultrasound Other: Transcranial doppler

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
Study Start Date : August 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients scheduled for CEA
All patients who are scheduled for carotid endarterectomy (CEA)
Other: Magnetic Resonance Imaging (MRI)
Multi-sequence MR protocol
Other Name: 3.0 T Philips Achieva

Radiation: Dual-Energy Computed Tomography (DECT)
Other Name: Siemens Flash

Other: Ultrasound
Other Name: Philips IU22

Other: Transcranial doppler
Other Name: Hemodynamics AG

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples Without DNA
Carotid plaque removed during carotid endarterectomy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01709045

Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Eline Kooi, PhD   
Sponsors and Collaborators
Maastricht University Medical Center
Center for Translational Molecular Medicine
Dutch Heart Foundation
Study Chair: Eline Kooi, PhD Maastricht University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center Identifier: NCT01709045     History of Changes
Other Study ID Numbers: 10-2-048
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013

Keywords provided by Maastricht University Medical Center:
Endarterectomy, Carotid
Carotid Arteries

Additional relevant MeSH terms:
Plaque, Atherosclerotic
Pathological Conditions, Anatomical