Improve Sudden Cardiac Arrest (SCA) Bridge Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,491
- 试验地点
- 52
- 主要终点
- Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
研究概览
简要总结
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic phase (≥40-90 days post-acute MI).
详细描述
To determine how many patients are referred for sudden cardiac death (SCD) risk stratification and management, indicated for implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (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
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above (or meet age requirements per local law)
- •Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI) ≤ 30 days of study enrollment and have a LVEF <50% measurement ≤ 14 days post-acute MI
- •Willing and able to give valid Informed Consent
排除标准
- •Patient has previously received 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 an 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
Percentage of Post-Acute MI Patients Who Are Referred for Sudden Cardiac Death Risk Stratification > Risk (SCD) Stratification and Management
时间窗: 3-months post-MI to 12-months post-MI
The numerator for this endpoint will be defined as the number of patients who met the clinician's determination to refer the subject for SCD risk stratification and management at any of the three follow-up visits. The denominator for this endpoint is the number of patients who completed a 3-month follow-up visit. While the participant study flow is composed of "referred" and "not referred" groups, these groups are simply the results of the referral process in the single arm of enrolled patients. Thus the analysis of the endpoints is conducted within this one arm. No hypotheses were tested for this endpoint.
次要结局
- Percentage of Post-Acute MI Patients Who Receive an ICD/CRT-D Within 12 Months Post-MI.(3-months post-MI to 12-months post-MI)
- Percentage of Post-Acute MI Patients Who Are Known to be Indicated for an ICD/CRT-D Within 12 Months Post-MI(3-months post-MI to 12-months post-MI)
- Percentage of ICD Indicated Patients Who Were Not Referred, Refused Referral or Refused Implant of an ICD(3-months post-MI to 12-months post-MI)
- Percentage of Post-Acute MI Patients Who Experience Cardiovascular Mortality(Enrollment to 12-months post-MI)
- Evolution of the Ejection Fraction Over the Immediate Period of Post MI(Enrollment to 3-months post-MI)