Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery: Post-discharge Follow-up of Patients From REN-004 Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Post-discharge outcomes for patients enrolled in REN-004 from one study center
研究概览
简要总结
This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient completed REN-004
- •Patient has at least 1 year of follow documentation post-discharge
排除标准
- •Patient enrolled in a clinical trial within 1-year post-discharge from REN-004
结局指标
主要结局
Post-discharge outcomes for patients enrolled in REN-004 from one study center
时间窗: 1 year
Readmission for any reason Rehospitalization related to procedure/valve/heart failure Contacts with HCP post discharge (any HCP) PCP (if available) All tests and procedures post discharge Medications Chronic kidney disease (CKD) - new diagnosis Acute kidney injury (AKI) requiring dialysis Chronic Kidney disease (CKD) requiring dialysis Atrial fibrillation - new-onset Myocardial infarction (MI) Non-fatal cardiac arrest Reoperation for coronary artery bypass graft (CABG) Reoperation for valve dysfunction Stroke Death from any cause MACCE Death from any cause, repeat revascularization (CABG or PCI), non-fatal MI, and stroke
次要结局
- Total estimated cost of in hospital and post-discharge(1 year)