ParisK: Correlation of Imaging Techniques With Histology

NCT01709045 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-10-27

No results posted yet for this study

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

  • Stroke
  • Plaque, Atherosclerotic

Interventions

OTHER

Magnetic Resonance Imaging (MRI)

Multi-sequence MR protocol

RADIATION

Dual-Energy Computed Tomography (DECT)

OTHER

Ultrasound

OTHER

Transcranial doppler

Sponsors & Collaborators

  • Center for Translational Molecular Medicine

    collaborator OTHER
  • Dutch Heart Foundation

    collaborator OTHER
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Eline Kooi, PhD · Maastricht University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709045 on ClinicalTrials.gov