Improve SCA Bridge
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 9
- 主要终点
- To characterize the proportion of post-acute MI patients who are referred for suddden cardiac death (SCD) risk startification and management.
研究概览
简要总结
Left ventricular dysfunction following an acute MI identifies patients at higher risk of sudden cardiac arrest (SCA) and sudden cardiac death SCD). SCD remains a leading cause of death in those who received revascularization, accounting for up to 40% of total deaths. The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute MI patients as a result of standard assessments of left ventricular ejection fraction in acute phase less than equal to 14 days post- acute MI) and chronic phase greater than or equal to 40-90 days post-acute MI). Specifically, how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for ICD/CRT-D implant, and how many receive such devices within 12 months of experiencing an MI
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 and above ( or meet age requirements per local law) Patients who have acute Myocardial Infarction ( MI) ( STEMI of Non-STEMI) less than equal to 30 days of study enrollment and have a LVEF less than 50% measurement less than equal to 14 days post-acute MI Willing and able to give valid Informed Consent.
排除标准
- •Patient has previously recieved or currently implanted with an ICD or CRT-D Patient has any contraindication for ICD/CRT-D Patient has a life expectancy of less than 12 months Patient who has had and EP referral within the last 12 months Any exclusion criteria required by local law (e.g. pregnancy, breast feeding etc.) Patient is unable ( e.g. mental disorder) or unwilling to be compliant with the responsibilities as specified in the informed consent form.
- •Patient is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader.
结局指标
主要结局
To characterize the proportion of post-acute MI patients who are referred for suddden cardiac death (SCD) risk startification and management.
时间窗: 12 months
次要结局
- Characterize the proportion of postâ€acute MI patients who are known to be indicated for an(ICD/CRTâ€D within 12 months postâ€acute MI.)