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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Correlation between sortilin serum levels before endovascular revascularization and incidence of restenosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Correlation between sortilin serum levels before endovascular revascularization and incidence of restenosis
时间窗: 12-months follow-up
To evaluate the association between sortilin serum levels before endovascular revascularization and restenosis during the follow-up period.
Correlation between sortilin serum levels before endovascular revascularization and incidence of acute limb ischemia
时间窗: 12-months follow-up
To evaluate the association between sortilin serum levels before endovascular revascularization and acute limb ischemia during the follow-up period.
Correlation between sortilin serum levels before endovascular revascularization and incidence of amputations
时间窗: 12-months follow-up
To evaluate the association between sortilin serum levels before endovascular revascularization and amputations during the follow-up period.
Correlation between sortilin serum levels before endovascular revascularization and chronic limb-threatening ischemia needing for urgent revascularization
时间窗: 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.
次要结局
未报告次要终点
研究者
Flex Andrea
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS