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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05759130
Other study ID # 1990
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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