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

Carotid Artery Disease Clinical Trial

— PLAVASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321410
• Other study ID #: CE 2674
• Status: Completed
• Phase: N/A
• First received: November 26, 2014
• Last updated: November 20, 2017
• Start date: February 2014
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: Ospedale San Giovanni Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Disease
• Carotid Artery Diseases
• Neovascularization, Pathologic
• Plaque Neovascularization

Intervention

Other:
• Contrast enhanced ultrasound of the carotid plaque
visual grading of neovessel
• Dynamic contrast-enhanced carotid plaque MRI
quantitative analysis of gadolinium enchantment in a region of interest

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona	Bellinzona	Canton Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Giovanni Bellinzona

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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 — View Citation

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-enh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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