National Tunisian Registry of Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,698
- 试验地点
- 1
- 主要终点
- MACE endopoint (Major adverse cardiovascular event)
研究概览
简要总结
The National Tunisian Registry of Percutaneous Coronary Intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) & ICH (International Conference on Harmonisation) requirements.
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
- •Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period
- •Informed and signed consent
排除标准
- •Withdrawn consent
结局指标
主要结局
MACE endopoint (Major adverse cardiovascular event)
时间窗: Time-To-Event measure up to 12 months from baseline
Composite endpoint (MACE: major adverse cardiovascular event) : occurence of cardiovascular death, or non fatal myocardial infraction, or non fatal stroke, or Target Lesion revascularisation, or Target Vessel Revascularisation
次要结局
- Death(Time-To-Event measure up to 12 months from baseline)
- PCI (Percutaneous Coronary Intervention)(Time-To-Event measure up to 12 months from baseline)