The Role of microRNA-210 in Regulating Oxidative Stress in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- miR-210 gene expression
研究概览
简要总结
MicroRNA-210 (miR-210) can be a potential therapeutic target of patients with peripheral artery disease (PAD). Recent evidence suggests the role of miR-210 and oxidative stress in the pathophysiology of PAD and its association with mitochondrial function, oxidative metabolism, walking distances and quality of life. The protocol evaluates the mechanisms which miR-210 regulates oxidative stress and provides evidence of potential therapeutic strategies.
详细描述
The investigators will randomize 180 PAD patients that undergoing a revascularization operation in two groups: (1) an endovascular procedure or (2) an open bypass procedure. They are also planning to recruit 50 non-PAD healthy control subjects.
The goal is to answer the main hypothesis that miR-210 gene expression is a master regulator of oxidative stress and is associated with mitochondrial dysfunction, oxidative metabolism, walking function and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female 30 years or older,
- •Infrainguinal PAD,
- •critical limb ischemia, defined as arterial insufficiency with gangrene, nonhealing ischemic ulcer, or rest pain consistent,
- •candidate for both endovascular and open infra-inguinal revascularization as judged by the vascular surgeons,
- •absence of musculoskeletal (most commonly arthritis related) or neurologic (most commonly back pain and sciatica related) symptoms,
- •willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
排除标准
- •life expectancy of less than 2 years due to reasons other than PAD,
- •acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma,
- •current chemotherapy or radiation therapy
研究组 & 干预措施
Revascularization group
Participants will be randomized to either an endovascular or an open bypass procedure.
干预措施: Revascularization operation (Procedure)
Control group
Healthy non-PAD participants will be recruited as control group
干预措施: Control group (Other)
结局指标
主要结局
miR-210 gene expression
时间窗: Change from baseline to six-month follow-up
Measure miR-210 gene expression at baseline and after intervention
Calf muscle biopsy biochemical measures
时间窗: Change from baseline to six-month follow-up
A skeletal muscle sample will be obtained from the gastrocnemius muscle.
次要结局
- Six-minute walk performance(Change from baseline to six-month follow-up)
- Graded treadmill walk performance(Change from baseline to six-month follow-up)
- The 36-Item Short Form questionnaire (SF-36)(Change from baseline to six-month follow-up)
- The Walking Impairment Questionnaire(Change from baseline to six-month follow-up)
研究者
Panagiotis Koutakis
Associate Professor
University of West Florida