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

Sponsor
Ospedale San Giovanni Bellinzona (Other)
Overall Status
Completed
CT.gov ID
NCT02321410
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
26
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Contrast enhanced ultrasound of the carotid plaque
  • Other: Dynamic contrast-enhanced carotid plaque MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Plaque Neovascularization Assessment by Contrast Ultrasounds and Plaque Magnetic Resonance: "in Vivo" Comparison in Human Carotid Atherosclerosis
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Plaque neovascularization grading and quantification (assessment by DCE-MRI) [Baseline]

    Contrast enhanced ultrasound plaque neovascularization grading , correlated to plaque neovascularization quantitative assessment by DCE-MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona Bellinzona Canton Ticino Switzerland 6500

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Professor Augusto Gallino, Professor MD, Ospedale San Giovanni Bellinzona
ClinicalTrials.gov Identifier:
NCT02321410
Other Study ID Numbers:
  • CE 2674
First Posted:
Dec 22, 2014
Last Update Posted:
Nov 22, 2017
Last Verified:
Nov 1, 2017
Additional relevant MeSH terms:
Carotid Artery Diseases
Atherosclerosis
Neovascularization, Pathologic

Study Results

No Results Posted as of Nov 22, 2017