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

Recruiting

• Conditions: Peripheral Artery Disease

• Registration Number: NCT05759130
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Status Verified: 2023-02
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-02-25
• Study First Posted: 2023-03-08
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-17
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 207

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy