NCT05759130

Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization

Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization in a Cohort of Diabetic Patients With Peripheral Artery Disease and Chronic Limb-threatening Ischemia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 207 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sortilin is a 95-kDa protein related to circulating cholesterol. It is found inside different cell types and circulating in blood and it has been associated with the risk of atherosclerosis development and cardiovascular diseases. The goal of this observational study is to evaluate the potential use of circulating sortilin as a biomarker of vascular adverse outcomes in patients with peripheral artery disease (PAD) and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization. The main questions it aims to answer are: * association between sortilin serum levels and risk of restenosis after lower extremity revascularization. * association between sortilin serum levels and acute limb ischemia, major vascular amputations, and limb-threatening ischemia needing for urgent revascularization after lower extremity revascularization. Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating sortilin before the endovascular procedure. Incidence of restenosis and acute limb ischemia, major vascular amputations, and limb-threatening ischemia needing for urgent revascularization will be collected in a 12-months follow-up and will be associated with sortilin serum levels at baseline.

Conditions

• Peripheral Artery Disease

Timeline

• Start date: 2019-10-24
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-03-08
• Last updated: 2023-03-17

Locations

1 site across 1 country: Italy