Naples PCI Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Number of patients with target-lesion revascularization
研究概览
简要总结
The aim of the Naples PCI registry is to collect prospective data on baseline clinical, laboratory, and angiographic characteristics of patients undergoing PCI for acute or chronic coronary artery disease. All patients receive clinical follow-up at hospital discharge and at 1-year follow-up with the objective to assess clinical outcomes, including death, cardiovascular death, myocardial infarction, stroke, stent thrombosis, target-lesion and target-vessel revascularization, contrast-induced acute kidney injury, and bleeding events.
详细描述
Percutaneous coronary intervention (PCI) constitutes the most commonly performed therapeutic procedure in cardiovascular medicine and one on the most frequent interventions performed in medicine. Since the introduction of the procedure more than 40 years ago, the safety and efficacy profile of PCI has steadily improved with continuous advances in the technique, equipment, and procedural success. In the late 1980s, the advent of coronary stents favored the widespread adoption of PCI in routine clinical practice by eliminating the risk of periprocedural abrupt closure related to coronary dissection and, as corollary, the need for standby emergent coronary artery bypass grafting. Nowadays, about three out of four patients requiring myocardial revascularization are managed PCI.
The objective of this study is to evaluate, within the framework of a prospective registry, the safety and efficacy of PCI by considering all device iterations including stent-based as well as non-stent-based interventions. We will evaluate clinical, laboratory, angiographic data of all patients undergoing PCI at the Federico II University Hospital. Clinical follow-up is collected during hospital stay and at 1-year after PCI. All adverse events are independently adjudicated by a clinical events committee (CEC).
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
- •Clinical evidence of coronary artery disease requiring PCI;
- •Age ≥18 years;
- •Written informed consent.
排除标准
- •Inability to provide informed consent.
结局指标
主要结局
Number of patients with target-lesion revascularization
时间窗: 12 months
Target lesion revascularization
Number of patients with death
时间窗: 12 months
Death
Number of patients with myocardial infarction
时间窗: 12 months
Myocardial infarction
Number of patients with stroke
时间窗: 12 months
Stroke
Number of patients with stent thrombosis
时间窗: 12 months
Stent thrombosis
Number of patients with contrast-induced acute kidney injury
时间窗: 12 months
Contrast-induced acute kidney injury
Number of patients with bleeding
时间窗: 12 months
Bleeding
Number of patients with target-vessel revascularization
时间窗: 12 months
Target vessel revascularization
次要结局
未报告次要终点
研究者
Giovanni Esposito
MD, PhD
Federico II University
