Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02321410
Study type Interventional
Source Ospedale San Giovanni Bellinzona
Contact
Status Completed
Phase N/A
Start date February 2014
Completion date April 2016

See also
  Status Clinical Trial Phase
Recruiting NCT02124928 - Morphological and Serological Criteria of Plaque Vulnerability: Risk Assessment for Symptomatic and Asymptomatic Carotid Artery Stenosis N/A
Active, not recruiting NCT01597453 - NOR-SYS: The Norwegian Stroke in the Young Study N/A
Completed NCT00744523 - Proximal Protection With The Mo.Ma Device During Carotid Stenting N/A
Completed NCT00231231 - Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS) Phase 3
Completed NCT00597974 - Neurological Outcome With Carotid Artery Stenting N/A
Completed NCT00587717 - The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue N/A
Completed NCT02536378 - POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
Completed NCT02126982 - Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence
Active, not recruiting NCT01445613 - Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy N/A
Terminated NCT01414387 - Effects of Cerebral Protection With Filters vs. Flow Reversal on Cerebral Embolization After Carotid Artery Stenting N/A
Completed NCT00403078 - SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Completed NCT00406055 - CHOICE: Carotid Stenting For High Surgical-Risk Patients Phase 4
Terminated NCT01968226 - TRACER RGD-K5 Carotid Plaque Imaging Study Phase 2
Completed NCT01685567 - Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure Phase 3
Completed NCT00402740 - Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) N/A
Completed NCT00287508 - Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study) Phase 4
Completed NCT00178672 - A Single Center of Carotid Stenting With Distal Protection for the Treatment of Obstructive Carotid Artery Disease Phase 4
Recruiting NCT02850588 - SVS VQI TransCarotid Revascularization Surveillance Project
Completed NCT02759653 - Norwegian Carotid Plaque Study
Withdrawn NCT01042912 - Frequency Analysis of Carotid Artery Disease N/A