Status:
UNKNOWN
The Carotid Artery Multi-modality Imaging Prognostic (CAMP) Study
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Collaborating Sponsors:
University of Florence
Azienda USL Toscana Nord Ovest
Conditions:
Carotid Artery Diseases
Carotid Artery Plaque
Eligibility:
All Genders
45-85 years
Brief Summary
Carotid artery disease is a main cause of ischemic stroke and vascular dementia, and a highly prevalent disease. There is uncertainty about the optimal management of patients with serendipitously or s...
Detailed Description
BACKGROUND AND RATIONALE Stroke is a most relevant health burden, the second most common cause of death and the third cause of disability worldwide. Stroke is a heterogeneous disorder with several di...
Eligibility Criteria
Inclusion
- Asymptomatic carotid artery lesions between 40 and 60%, at carotid artery ultrasound, for which lesions an interventional strategy - beside optimal medical therapy - is not clearly defined.
- Patients with asymptomatic carotid artery stenosis higher than 60% will be enrolled when revascularization by either carotid endarterectomy (CEA) or stenting will be considered not indicated or not feasible
- Both genders (with capping implemented in order to ensure a 50±5% balance of males to females),
Exclusion
- Severe comorbidities a priori precluding the 2-year follow-up (cachexia; end-stage cancer; severe renal/respiratory insufficiency; advanced (class IV) heart failure; atrial fibrillation and other significant arrhythmias).
- Severe allergic diathesis; contraindications to contrast agents for angio-TC or MRI; claustrophobia; presence of prostheses/implanted electronic devices not suitable for MRI; lack of consent for any reason.
Key Trial Info
Start Date :
October 7 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 19 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04679727
Start Date
October 7 2020
End Date
July 19 2024
Last Update
November 15 2022
Active Locations (1)
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1
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy, 56124