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

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759130
• Other study ID #: 1990
• Status: Recruiting
• Start date: October 24, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Andrea Flex, MD, PhD
• Phone: +39 06 3015 4293
• Email: andrea.flex[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 207
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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