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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05759130
• Collaborator: (none)
• Enrollment: 207
• Location: 1
• Anticipated Duration (Months): 60.3
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease

Study Design

• Study Type: Observational
• Anticipated Enrollment: 207 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 24, 2019
• Anticipated Primary Completion Date: Oct 31, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Outcome Measures

Primary Outcome Measures

1. Association between incidence of restenosis and sortilin serum levels [12-months follow-up]

   To evaluate the association between sortilin serum levels before endovascular revascularization and restenosis during the follow-up period.

2. Association between incidence of acute limb ischemia and sortilin serum levels [12-months follow-up]

   To evaluate the association between sortilin serum levels before endovascular revascularization and acute limb ischemia during the follow-up period.

3. Association between incidence of amputations and sortilin serum levels [12-months follow-up]

   To evaluate the association between sortilin serum levels before endovascular revascularization and amputations during the follow-up period.

4. Association between incidence of limb-threatening ischemia needing for urgent revascularization and sortilin serum levels [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome		Italy

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Andrea Flex, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Flex Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05759130
• Other Study ID Numbers: 1990
• First Posted: Mar 8, 2023
• Last Update Posted: Mar 8, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Flex Andrea, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS: Sortilin; Peripheral Artery Disease; Restenosis; Acute limb ischemia; Amputation; Limb-threatening ischemia
• Additional relevant MeSH terms: Peripheral Arterial Disease

Study Results

No Results Posted as of Mar 8, 2023