Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01709045
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2012-10-16
Brief Title:
ParisK Correlation of Imaging Techniques With Histology
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
The Assessment of the Plaque at RISK by Non-invasive Molecular Imaging and Modelling ParisK Correlation of Imaging Techniques With Histology
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ParisK
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 andor 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 andor 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 30 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
The primary goal of this study is to investigate whether there is a correlation between neovascularisation in the carotid atherosclerotic plaque as observed with 30 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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None