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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Peripheral Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus diagnosis; Ankle/Brachial Index (ABI) of less than 80; at least one lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US); stage 4 or 5 PAD diagnosis according to the Rutherford classification; presence of chronic limb threatening ischemia; indication for LER of the target arterial stenosis. Exclusion Criteria: statin therapy within the previous 3 months; revascularization of the lower limb in the previous 3 months; diabetic foot ulcers with signs of active infection or osteomyelitis; diabetic peripheral neuropathy; homozygous familial hypercholesterolemia; absolute contraindication to antiplatelet therapy; thrombophilia; active cancer; active autoimmune disease; liver disease at functional status B or C according to Child-Pugh.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between sortilin serum levels before endovascular revascularization and incidence of restenosis | To evaluate the association between sortilin serum levels before endovascular revascularization and restenosis during the follow-up period. | 12-months follow-up | 
| Correlation between sortilin serum levels before endovascular revascularization and incidence of acute limb ischemia | To evaluate the association between sortilin serum levels before endovascular revascularization and acute limb ischemia during the follow-up period. | 12-months follow-up | 
| Correlation between sortilin serum levels before endovascular revascularization and incidence of amputations | To evaluate the association between sortilin serum levels before endovascular revascularization and amputations during the follow-up period. | 12-months follow-up | 
| Correlation between sortilin serum levels before endovascular revascularization and chronic limb-threatening ischemia needing for urgent revascularization | To evaluate the association between sortilin serum levels before endovascular revascularization and limb-threatening ischemia needing for urgent revascularization during the follow-up period. | 12-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sortilin, Peripheral Artery Disease, Restenosis, Acute limb ischemia, Amputation, Limb-threatening ischemia