Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Occurrence of serious complications of cardiac catheterization in congenital heart
研究概览
简要总结
Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.
详细描述
Patients admitted in the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Participants release the data in (e-CRF) electronics system. Sample: 2000 records.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Day 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization.
排除标准
- •Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.
结局指标
主要结局
Occurrence of serious complications of cardiac catheterization in congenital heart
时间窗: December 2014
Occurrence of serious complications of cardiac catheterization in congenital heart procedure-related (occurring within 7 days after the procedure or until hospital discharge, whichever occurs first, and following 30 days), such as embolization of the prosthesis, cardiac arrhythmias, trauma vascular intracardiac injury, death, etc
次要结局
未报告次要终点