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

NCT05759130 | Unknown

• 1 other identifier: 1990
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

Sortilin; Peripheral Artery Disease; Restenosis; Acute limb ischemia; Amputation; Limb-threatening ischemia

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Andrea Flex, MD, PhD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Flex, MD, PhD

CONTACT

+39 06 3015 4293; andrea.flex@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 8, 2023
• Study Start: October 24, 2019
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-02

Locations

IT (1)