ParisK: Correlation of Imaging Techniques With Histology

Stroke Clinical Trial

— ParisK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01709045
• Other study ID #: 10-2-048
• Status: Completed
• Start date: August 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque, Atherosclerotic
• Stroke

Intervention

Other:
• Magnetic Resonance Imaging (MRI)
Multi-sequence MR protocol

Radiation:
• Dual-Energy Computed Tomography (DECT)

Other:
• Ultrasound

• Transcranial doppler

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Center for Translational Molecular Medicine, Dutch Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ktrans on dynamic contrast-enhanced (DCE)-MRI	The correlation between neovascularisation in carotid atherosclerotic plaque as assessed by dynamic 3.0 Tesla MRI and microvasculature as assessed by histology.	1 day
Primary	Lipid-rich necrotic core on dual-energy CT	The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.	1 day
Secondary	deformation pattern on ultrasound	The correlation between deformation pattern at echo and plaque composition (volume of LRNC) at histology.	1 day
Secondary	number of recorded micro embolic signals (MES)	The relation between number of recorded MES and fibrous cap status at histology.	1 day
Secondary	Volume of LRNC and calcifications and fibrous cap status on MRI	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.	1 day