Cardiovascular Biomarkers in Diabetic Patients Undergoing Endovascular Revascularization for Chronic Limb-threatening Ischemia (CLTI).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Association between incidence of MALE and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels
研究概览
简要总结
Despite the best medical management, many patients with peripheral artery disease (PAD) who undergo lower extremity endovascular revascularization experience adverse cardiovascular outcomes and postoperative complications that may increase the risk of acute limb ischemia or amputation. There are no clear molecular associations that could explain the differences in outcomes after endovascular therapy in patients with PAD. The variable outcomes following endovascular therapy may depend, at least in part, on the profile of cytokines involved in inflammatory and atherosclerotic processes.
The goal of this observational study is to evaluate the potential use of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 levels as biomarkers of major adverse limb events (MALE) and major adverse cardiovascular events (MACE) in diabetic patients with PAD and chronic limb-threatening ischemia (CLTI) requiring a procedure of endovascular revascularization.
The main questions it aims to answer are:
- association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse limb events (MALE) after lower extremity revascularization.
- association between serum levels of IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 at baseline and major adverse cardiovascular events (MACE) after lower extremity revascularization.
Diabetic patients with CLTI requiring lower extremity endovascular revascularization will undergo blood sampling for the dosage of circulating IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 before the endovascular procedure.
Incidence of MALE and MACE will be collected in a 12-months follow-up and will be associated with IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels.
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
- •age of at least 18 years
- •diagnosis of T2DM present for a least one year
- •Ankle/Brachial Index (ABI) of less than 0.80
- •lower limb stenosis greater than 50% documented by Ultrasound Color Doppler (US)
- •category 4 or 5 of PAD in accordance with the Rutherford classification
- •presence of CLTI requiring endovascular treatment
排除标准
- •pregnancy
- •acute infections at present or in the previous month
- •diabetic foot ulcers with sign of infection or osteomyelitis
- •previous lower-limb endovascular or surgical revascularization within the past 3 months
- •diabetic peripheral neuropathy
- •liver disease with a functional status B or C in accord to Child-Pugh classification
- •congenital or acquired thrombophilia
- •active autoimmune disease
- •active cancer
- •organ transplantation
- •life expectancy < 12 months
- •contraindication to antiplatelet therapy
- •contraindication to endovascular revascularization
结局指标
主要结局
Association between incidence of MALE and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels
时间窗: 12-months follow-up
To evaluate the association between IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels before endovascular revascularization and incidence of MALE during the follow-up period.
次要结局
- Association between incidence of cardiovascular death and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels(12-months follow-up)
- Association between incidence of myocardial infarction and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels(12-months follow-up)
- Association between incidence of stroke and IL-1, IL-6, TNF-alpha, C reactive protein, HMGB-1, osteoprotegerin, sortilin and omentin-1 serum levels(12-months follow-up)
研究者
Flex Andrea
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS