"In Vivo" Comparison in Human Carotid Atherosclerosis: Plaque Neovascularization (PLAVASC)

November 20, 2017 updated by: Professor Augusto Gallino, Ospedale San Giovanni Bellinzona

Plaque Neovascularization Assessment by Contrast Ultrasounds and Plaque Magnetic Resonance: "in Vivo" Comparison in Human Carotid Atherosclerosis

Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the abrupt coronary or cerebrovascular events occurring following the transition from a stable to an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are complex and probably multiple. There is increasing evidence that, besides inflammation, neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important role in plaque instability ending-up frequently in acute thrombotic occlusion or distal embolisation of athero-thrombotic material associated with heart attack or stroke. Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance microvascular structures and to visualize the adventitia and intraplaque vascularization. Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo detection and quantification of plaque neovascularity. Together with the presence of a large lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate, plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as demonstrated in histopathological studies using microvessel density.

Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS), a bed-side technique, in detecting plaque neovascularisation and compare it with the quantitative assessment by DCE-MRI in carotis atherosclerosis.

A group of 30 patients with asymptomatic carotid atherosclerosis (> 50% stenosis on Doppler ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and DCE-MRI will be performed in the same patients and will be analyzed by two separate operators blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with in vivo DCE-MRI, as the standard of reference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic 50-70% carotid artery stenosis on Doppler ultrasound
  • Asymptomatic >70% carotid artery stenosis on Doppler ultrasound (no surgical indication)
  • Signed informed consent

Exclusion Criteria:

  • Non atherosclerotic occlusive disease
  • Prior carotid endarterectomy on the site of the index carotid artery
  • Contraindications for MRI and CE MRI (history of hypersensitivity to gadolinium salt, pacemaker or vascular clip implantation, implantation of any metallic device, severe claustrophobic reactions)
  • Contraindications to CEUS (hypersensitivity to Sonovue compounds, acute coronary syndromes, acute heart failure, heart failure in NYHA class III or IV, severe arrhythmias, known right-to-left cardiac shunt, severe pulmonary hypertension, uncontrolled arterial hypertension, acute distress respiratory syndrome)
  • Short-term life-threatening pathology (life expectancy < 6 months)
  • Physically unable to participate in the study
  • Compliance not guaranteed
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Imaging of carotid plaque
Patient undergo contrast enhanced ultrasound of the carotid plaque and dynamic contrast-enhanced carotid plaque MRI
Other: Contrast enhanced ultrasound of the carotid plaque
visual grading of neovessel
Other: Dynamic contrast-enhanced carotid plaque MRI
quantitative analysis of gadolinium enchantment in a region of interest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque neovascularization grading and quantification (assessment by DCE-MRI)
Time Frame: Baseline
Contrast enhanced ultrasound plaque neovascularization grading , correlated to plaque neovascularization quantitative assessment by DCE-MRI.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Giovanni Bellinzona

Investigators

  • Principal Investigator: Augusto Gallino, Prof. MD, Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona
  • Study Chair: Mattia Cattaneo, MD, Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

November 22, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE 2674

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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