2024-511894-32-00招募中3 期
The assessment of cysteinyl leukotriene receptor antagonist role in inhibition of atherosclerosis, proliferation and its influence on endothelial function in patients undergoing endovascular treatment due to peripheral arterial disease.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Restenosis in a previously treated artery
研究概览
简要总结
The main goal of this study is to investigate the influence of the use of cysteinyl leukotrienes receptor antagonists on lower limbs arteries reocclusion rate in patients with peripheral artery occlusive disease (PAOD) after endovascular treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with PAOD qualified for PTAvin the Angiology Department UJ CM, with Rutherford 3 or 4 clinical symptoms.
- •Age 45 - 75 years old.
- •Signed informed consent.
- •Citizen of Malopolska region
排除标准
- •Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
- •Buerger Disease.
- •Chronic heart failure (3-4 NYHA)
- •Acute lower limb ischemia or surgical revascularization within last 6 months.
- •Serious trauma or surgery procedure within last 6 months.
- •Ongoing antileukotriene treatment
- •Neoplasm diagnosed within 5 years.
- •Chronic Kidney Disease (creat. >177 μmol/l).
- •Pregnancy, puerperium, women without efficient contraception.
- •Vaccinations within 30 days before recruitment.
- •Age < 45 or > 75 years old.
- •Hospitalisation in intensive care unit within 3 months.
- •Lack of the possibility of the follow-up participation.
- •Infection and/or fever (temperature above 37,2 C) within the last 3 weeks preceding the study recruitment (viral infections, cold, sinusitis) and use of antibiotics within the last 2 months.
- •Symptoms of acute tissue infection
- •Chronic inflammatory disease (e.g. COPD stage >II in GOLD classification)
- •HIV+, HCV+, HBS+.
- •Autoimmunological diseases and use of steroids or immunosuppressive medications within the last 3 months.
- •Inflammatory blood vessel disorders (with exception of atherosclerosis)
- •Myocardial infarction or stoke within last 6 months.
结局指标
主要结局
Restenosis in a previously treated artery
Restenosis in a previously treated artery
次要结局
- MACE, high lower limb amputation, significant loss in quality of life
研究者
Paweł Maga
Scientific
Uniwersytet Jagiellonski Collegium Medicum
研究点 (1)
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