ParisK: Correlation of Imaging Techniques With Histology

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Maastricht University Medical Center
Sponsor:
Collaborators:
Center for Translational Molecular Medicine
Dutch Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01709045
First received: October 16, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Stroke
Plaque, Atherosclerotic
Other: Magnetic Resonance Imaging (MRI)
Radiation: Dual-Energy Computed Tomography (DECT)
Other: Ultrasound
Other: Transcranial doppler

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Assessment of the Plaque at RISK by Non-invasive (Molecular) Imaging and Modelling (ParisK): Correlation of Imaging Techniques With Histology

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Ktrans on dynamic contrast-enhanced (DCE)-MRI [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The correlation between the size of lipid-rich-necrotic-core in dual-energy CT and histology.


Secondary Outcome Measures:
  • deformation pattern on ultrasound [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Carotid plaque removed during carotid endarterectomy


Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients scheduled for CEA
All patients who are scheduled for carotid endarterectomy (CEA)
Other: Magnetic Resonance Imaging (MRI)
Multi-sequence MR protocol
Other Name: 3.0 T Philips Achieva
Radiation: Dual-Energy Computed Tomography (DECT)
Other Name: Siemens Flash
Other: Ultrasound
Other Name: Philips IU22
Other: Transcranial doppler
Other Name: Hemodynamics AG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a carotid artery stenosis, who are scheduled for carotid endarterectomy, will be included.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709045

Locations
Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands
Contact: Eline Kooi, PhD       eline.kooi@mumc.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Center for Translational Molecular Medicine
Dutch Heart Foundation
Investigators
Study Chair: Eline Kooi, PhD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01709045     History of Changes
Other Study ID Numbers: 10-2-048
Study First Received: October 16, 2012
Last Updated: September 12, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Endarterectomy, Carotid
Carotid Arteries

Additional relevant MeSH terms:
Stroke
Plaque, Atherosclerotic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 21, 2014