RESTenosis in Patients With Contact ALLergy to Metals Zabrze Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- Major Adverse Cardiovascular Events (MACE)
研究概览
简要总结
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Study objectives is the analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence. The angiographic results of stent implantation, and in-stent restenosis will be assessed independently by two skilled interventional cardiologists, and in case of their discrepant opinions, the decision will be made on the basis of the third cardiologist. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.
详细描述
Introduction:
In-stent restenosis remains one of the most challenging problems in patients after coronary artery angioplasty. Angiographically, it is discovered in 10% of the patients after drug-eluting stent (DES) implantation. There are multiple factors causing restenosis, which can be divided into two major groups: first vessel-dependent (based on the vessel's tortuosity, dimensions and lesion's calcification, all leading to suboptimal stent expansion), and second dependent on the inflammatory processes caused by the intervention. Although the proper stent expansion depends mostly on the cardiologist's manual dexterity, the inflammation development does totally not depend on the operator. The allergic reactions to metals are likely to be one of the underlying causes of inflammation. Among the most prevalent allergens, cobalt, chromium, nickel, and tungsten used as the stent materials are causing the most intensive contact allergic reaction. The allergic process induced by the aforementioned metals belongs to type IV contact allergy (T-cell mediated). Stent implantation results in life-long contact with metal, thus in allergic patients, it is likely to develop local reactions leading to in-stent restenosis. Up to date, there have been approximately one thousand in-stent restenosis cases documented in patients with confirmed contact allergy to stent metals.
Study objectives:
Analysis of the possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.
Materials and methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •angiographically proven in-stent restenosis after technically correct implantation
- •technically correctly implanted stent
排除标准
- •autoimmune diseases (e.g., rheumatoid arthritis)
- •immunodeficiency syndromes (e.g., HIV infection)
- •chronic use of immunosuppressive drugs and/or corticosteroids
- •skin lesions that may attenuate the reading of skin tests
- •previous coronary artery bypass surgery (in subgroup 1) or planned coronary artery bypass surgery (in subgroup 2)
- •any surgical procedure with metal implants (in the past or planned within 12 months of observation)
研究组 & 干预措施
Metal allergy driven restenosis
Patients with angiographically proven in-stent restenosis developed after technically correct implantation. Patch tests for the metals used in stent production will be applicated. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.
干预措施: In-stent restenosis (Biological)
Looking for allergic restenosis
Patients with (technically correctly) implanted stent. Patch tests will be applicated to identify cases with contact allergy. The tests will be applicated during the hospitalisation, then read after 48 hours and 72 hours, and subsequently interpreted by the skilled dermatologist, during the hospital stay or afterwards.The patients will then be monitored for a 12 months follow-up period in purpose of evaluating the dependance between in-stent restenosis and contact allergy. Possible correlation between allergy to metals utilised during the stent manufacturing (nickel, cobalt, chromium, molybdenum, tungsten) and in-stent restenosis occurence.
干预措施: In-stent restenosis (Biological)
结局指标
主要结局
Major Adverse Cardiovascular Events (MACE)
时间窗: 12 months
In-stent restenosis, acute myocardial infarction (AMI), death, cardiovascular (CV) death
次要结局
未报告次要终点
研究者
Mariusz Gasior
Professor of Medicine, Head of III Dept. of Cardiology
Silesian Centre for Heart Diseases