Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02321410
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2014-11-26
Brief Title:
In Vivo Comparison in Human Carotid Atherosclerosis Plaque Neovascularization
Sponsor:
Ospedale San Giovanni Bellinzona
Organization:
Ospedale San Giovanni Bellinzona
Study Overview
Official Title:
Plaque Neovascularization Assessment by Contrast Ultrasounds and Plaque Magnetic Resonance in Vivo Comparison in Human Carotid Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLAVASC
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None