NCT05757271

Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease

Serum Levels of Klotho as a Possible Biomarker of Peripheral Artery Disease Progression

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 207 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Klotho, a membrane-bound protein co-receptor for fibroblast growth factor 23 (FGF23), is involved in atherosclerotic process and cardiovascular diseases. It regulates blood glucose and cholesterol levels. In addition, the lack of klotho has been associated with endothelial dysfunction, calcification and accumulation of cholesterol in the arteries, leading to coronary heart disease. The goal of this observational study is to evaluate the potential use of circulating klotho and FGF23 serum levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) 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 klotho and FGF23 serum levels and major adverse limb events (MALE) after lower extremity revascularization. * association between klotho and FGF23 serum levels and major adverse cardiovascular events (MACE) after lower extremity revascularization. Patients with PAD and CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating klotho and FGF23 before the endovascular procedure. Incidence of MACE and MALE will be collected in a 12-months follow-up and will be associated with klotho and FGF23 serum levels at baseline.

Conditions

• Peripheral Arterial Disease

Timeline

• Start date: 2019-10-23
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2023-03-07
• Last updated: 2023-03-07

Locations

1 site across 1 country: Italy