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

NCT02321410 | Completed DMC

• 1 other identifier: CE 2674
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease; Plaque Neovascularization

Outcome Measures

Primary Outcomes (1)

• Plaque neovascularization grading and quantification (assessment by DCE-MRI)

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

  Baseline

Study Arms (1)

Imaging of carotid plaque

OTHER

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

Other: Contrast enhanced ultrasound of the carotid plaque; Other: Dynamic contrast-enhanced carotid plaque MRI

Interventions

Contrast enhanced ultrasound of the carotid plaque OTHER

visual grading of neovessel

Imaging of carotid plaque

Dynamic contrast-enhanced carotid plaque MRI OTHER

quantitative analysis of gadolinium enchantment in a region of interest

Imaging of carotid plaque

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Giovanni Bellinzona: lead

Study Sites (1)

Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 27752526 RESULT

• 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.

  PMID: 27597156 RESULT

• 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.

  PMID: 31661690 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Augusto Gallino, Prof. MD

  Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

  PRINCIPAL INVESTIGATOR

• Mattia Cattaneo, MD

  Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 22, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

CH (1)