Outcome Reflection for Immune Mediated Rejection by Utilizing Artificial Intelligence in Cardiac Transplant Patients Through Early and Late Echocardiographic Analysis (ORACLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5%
研究概览
简要总结
The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and/or point of care ultrasound).
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
- •Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.
排除标准
- •Refusal of study participation
结局指标
主要结局
Number of episodes identified by the Artificial Intelligence (AI) algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to <50%, or a drop in LVEF >5%
时间窗: 2 years
Number of episodes identified by the AI algorithm as 1R or greater acute cellular rejection, grade 1 or greater antibody mediated rejection, reduction in LVEF to \<50%, or a drop in LVEF \>5% utilizing electrocardiograms and cardiac ultrasound images/videos obtained from point of care ultrasound (POCUS) or echocardiograms.
次要结局
未报告次要终点
研究者
Atta Behfar MD, PhD
Principal Investigator
Mayo Clinic