Trials / Completed
CompletedNCT01709045
ParisK: Correlation of Imaging Techniques With Histology
The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (actual)
- Sponsor
- Maastricht University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Magnetic Resonance Imaging (MRI) | Multi-sequence MR protocol |
| RADIATION | Dual-Energy Computed Tomography (DECT) | |
| OTHER | Ultrasound | |
| OTHER | Transcranial doppler |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2014-12-01
- Completion
- 2014-12-01
- First posted
- 2012-10-17
- Last updated
- 2023-10-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01709045. Inclusion in this directory is not an endorsement.