Carotid Artery Disease Clinical Trial
— PLAVASCOfficial title:
Plaque Neovascularization Assessment by Contrast Ultrasounds and Plaque Magnetic Resonance: "in Vivo" Comparison in Human Carotid Atherosclerosis
Verified date | November 2017 |
Source | Ospedale San Giovanni Bellinzona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Ospedale Regionale di Bellinzona e Valli - Ospedale San Giovanni Bellinzona | Bellinzona | Canton Ticino |
Lead Sponsor | Collaborator |
---|---|
Ospedale San Giovanni Bellinzona |
Switzerland,
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
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 |
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