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

NCT ID: NCT02321410

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Artery Disease Plaque Neovascularization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging of carotid plaque

Patient undergo contrast enhanced ultrasound of the carotid plaque and dynamic contrast-enhanced carotid plaque MRI

Group Type OTHER

Contrast enhanced ultrasound of the carotid plaque

Intervention Type OTHER

visual grading of neovessel

Dynamic contrast-enhanced carotid plaque MRI

Intervention Type OTHER

quantitative analysis of gadolinium enchantment in a region of interest

Interventions

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Contrast enhanced ultrasound of the carotid plaque

visual grading of neovessel

Intervention Type OTHER

Dynamic contrast-enhanced carotid plaque MRI

quantitative analysis of gadolinium enchantment in a region of interest

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Giovanni Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Professor Augusto Gallino

Professor MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Augusto Gallino, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Mattia Cattaneo, MD

Role: STUDY_CHAIR

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Locations

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Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Bellinzona, Canton Ticino, Switzerland

Site Status

Countries

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Switzerland

References

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Cattaneo M, Staub D, Porretta AP, Gallino JM, Santini P, Limoni C, Wyttenbach R, Gallino A. Data on consistency among different methods to assess atherosclerotic plaque echogenicity on standard ultrasound and intraplaque neovascularization on contrast-enhanced ultrasound imaging in human carotid artery. Data Brief. 2016 Oct 3;9:563-567. doi: 10.1016/j.dib.2016.09.041. eCollection 2016 Dec.

Reference Type RESULT
PMID: 27752526 (View on PubMed)

Cattaneo M, Staub D, Porretta AP, Gallino JM, Santini P, Limoni C, Wyttenbach R, Gallino A. Contrast-enhanced ultrasound imaging of intraplaque neovascularization and its correlation to plaque echogenicity in human carotid arteries atherosclerosis. Int J Cardiol. 2016 Nov 15;223:917-922. doi: 10.1016/j.ijcard.2016.08.261. Epub 2016 Aug 16.

Reference Type RESULT
PMID: 27597156 (View on PubMed)

Cattaneo M, Sun J, Staub D, Xu D, Gallino JM, Santini P, Porretta AP, Yuan C, Balu N, Arnold M, Froio A, Limoni C, Wyttenbach R, Gallino A. Imaging of Carotid Plaque Neovascularization by Contrast-Enhanced Ultrasound and Dynamic Contrast-Enhanced Magnetic Resonance Imaging. Cerebrovasc Dis. 2019;48(3-6):140-148. doi: 10.1159/000504042. Epub 2019 Oct 29.

Reference Type DERIVED
PMID: 31661690 (View on PubMed)

Other Identifiers

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CE 2674

Identifier Type: -

Identifier Source: org_study_id