Long-term Prognosis of Interventional Therapy in Patients With Lower Extremity Arterial Occlusive Disease and Its Risk Factors
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Ankle-brachial index
研究概览
简要总结
Along with the improvement of living standard, the prevalence of Lower extremity arterial occlusive disease (LEAOD) is also increasing, which has become an important cause of lower extremity amputation and greatly affected the patients' life quality. Currently, percutaneous transluminal angioplasty (PTA), including balloon dilatation and stent implantation, has been regarded as the most widely applied and accepted treatment for LEAOD. The therapeutic effects of lower extremity interventional treatment, varied in different reports. It was reported that the therapeutic effects were influenced by some traditional risk factors, including age, gender, smoking, and so on. More risk factors are still unknown. The difference of therapeutic effects, the endpoint events were compared between interventional and conventional treatment group to analyze the effect of interventional treatment on LEAOD and explore its risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age between 40-90 years old.
- •Ankle-brachial index(ABI)<0.
- •Lower extremity arterial CT shows that the arterial stenosis>50%
排除标准
- •Type 2 diabetes with acute complications.
- •Type 1 diabetes.
- •Cerebrovascular diseases in the last 3 months.
- •Cardiovascular diseases (myocardial infarction, angina, cardiac failure) in the last 3 months.
- •Hemorrhagic disease.
- •Hypohepatia (AST or AST is twice higher than the upper limit) or cirrhosis, hepatic encephalopathy.
- •History of dialysis.
- •Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hypoxemia.
- •Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- •Fertile woman without contraceptives.
- •Allergic to iodine.
- •Unable to understanding and follow the study protocol orientations.
结局指标
主要结局
Ankle-brachial index
时间窗: Change from baseline at 1 year(End of Trial)
Incidence of amputation(%)
时间窗: 1 year(End of Trial)
Mortality(%)
时间窗: 1 year(End of Trial)
次要结局
- triglyceride(mmol/L)(Change from baseline at 1 year(End of Trial))
- High-sensitive C reactive protein(mg/L)(Change from baseline at 1 year(End of Trial))
- Fasting plasma glucose(mmol/L)(Change from baseline at 1 year(End of Trial))
- Blood pressure(mmHg)(Change from baseline at 1 year(End of Trial))
- HDL-c(mmol/L)(Change from baseline at 1 year(End of Trial))
- The lower limb transcutaneous oxygen pressure(mmHg)(Change from baseline at 1 year(End of Trial))
- total cholesterol(mmol/L)(Change from baseline at 1 year(End of Trial))
- LDL-c(mmol/L)(Change from baseline at 1 year(End of Trial))
- Incidence of major adverse cardiac events (MACE)(%)(1 year(End of Trial))
- HbA1c(%)(Change from baseline at 1 year(End of Trial))
研究者
Zhiming Zhu
MD, PhD
Third Military Medical University