Acute coRonary sYndrOmes proSpective regisTry Of Ferrara
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 1-year combined primary endpoint
研究概览
简要总结
The ARYOSTO has been designed to describe the clinical epidemiology and the current management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors will evaluate the medical and interventional management of ACS patients admitted to hospitals in the area of Ferrara and receiving coronary artery angiography and percutaneous coronary intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria di Ferrara, Cona (FE), Italy)
详细描述
The Cardiovascular Institute of the University Hospital of Ferrara is the hub center of the area of Ferrara (400.000 residents). The cath-lab of the University Hospital of Ferrara is the hub center of the network for the management of patients with ACS. This finding guarantees a very high number of patients with ACS admitted to University Hospital of Ferrara (more than 1500 by year). In the cath-lab are performed more than 2000 coronary artery angiography by year and more than 1100 PCI by year. The staff of the cardiology unit has a great experience in the management of studies (investigator-driven, randomized controlled trials, with or without sponsor) enrolling patients with ACS and treated with PCI. All consecutive patients with ACS admitted to hospitals of the Ferrara area will be included in the registry. All data will be related to long-term clinical outcome.
METHODS:
Prospective collection of following data:
- baseline characteristics including cardiovascular (CV) risk factors, CV history and comorbidities (see below)
- clinical management (CV drugs, imaging exams, diagnostic exams, time to cath-lab access)
- biomarkers evaluating inflammation, endothelial, platelet, thrombotic function and activation
- procedural details including coronary disease description, intervention modality, stent, coronary imaging, CV drugs during intervention, procedural complications and management, access site
- in-hospital adverse events
- medical treatment at discharge and during the follow-up
- clinical follow-up (1, 2, 3, 4 5 years)
PRE-SPECIFIED SUBSTUDY
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age >18 years
- •hospital admission for acute coronary syndromes
- •resident in the Ferrara area
排除标准
- 未提供
结局指标
主要结局
1-year combined primary endpoint
时间窗: 1 year
1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
次要结局
- 3-year combined endpoint(3 years)
- primary safety outcome(1 year)
- 2-year combined endpoint(2 years)
- cardiac adverse events(1, 2, 3, 4, 5 years)
- annual occurrence of single components of primary endpoint(1, 2, 3, 4, 5 years)
- 5-year combined endpoint(5 years)
- respiratory adverse events(1, 2, 3, 4, 5 years)
研究者
Gianluca Campo
Assistant Professor and Interventional Cardiologist
University Hospital of Ferrara