Clinical Trial: ParisK: Correlation of Imaging Techniques With Histology

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome:

• 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.
• 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.

Original Primary Outcome:

• Ktrans on 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.
• 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.

Current Secondary Outcome:

• deformation pattern on ultrasound [ Time Frame: 1 day ]
  The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
• number of recorded micro embolic signals (MES) [ Time Frame: 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 [ 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.

Original Secondary Outcome:

• deformation pattern on ultrasound [ Time Frame: 1 day ]
  The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.
• number of recorded micro embolic signals [ Time Frame: 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 [ 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.

Information By: Maastricht University Medical Center

Dates:
Date Received: October 16, 2012
Date Started: August 2011
Date Completion: December 2014
Last Updated: September 12, 2013
Last Verified: September 2013