Clinical trial NCT05759130: Utility of Sortilin as a Biomarker of Restenosis After Lower Extremity Endovascular Revascularization
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Keywords: Sortilin
Peripheral Artery Disease
Restenosis
Acute limb ischemia
Amputation
Limb-threatening ischemia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will enroll consecutive statin-naïve subjects with type 2 diabetes mellitus with PAD requiring for endovascular revascularization and admitted to Internal Medicine Cardiovascular Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between sortilin serum levels before endovascular revascularization and incidence of restenosis
timeFrame: 12-months follow-up
measure: Correlation between sortilin serum levels before endovascular revascularization and incidence of acute limb ischemia
timeFrame: 12-months follow-up
measure: Correlation between sortilin serum levels before endovascular revascularization and incidence of amputations
timeFrame: 12-months follow-up
measure: Correlation between sortilin serum levels before endovascular revascularization and chronic limb-threatening ischemia needing for urgent revascularization
timeFrame: 12-months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Andrea Flex, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: