EUCTR2020-000715-71-PL进行中（未招募）1 期
The assessment of cysteinyl leukotriene receptor antagonist role in inhibition of atherosclerosis, proliferation and its influence on endothelialfunction in patients undergoing endovascular treatment due to peripheral arterial disease. - CADET-PAD
Jagiellonian University Medical College0 个研究点目标入组 200 人开始时间: 2021年1月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •? Patients with peripheral arterial disease (PAOD) with Rutherford 1,2,5 or 6 clinical symptoms.
- •? Age < 45 or > 75 years old.
- •? 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.
- •? 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.
- •? On-going 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.
- •? Hospitalisation in intensive care unit within 3 months.
- •? Lack of the possibility of the follow-up participation.
研究者
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