NCT05714228已完成不适用
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,645
- 试验地点
- 1
- 主要终点
- Euroscore II predictive power for surgery
研究概览
简要总结
The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery
- However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.
- The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation.
Methods
- Institutional database retrospective review for surgical mitral repair and MitraClip implantation.
- Time frame: January 2012-December 2019
- 2793 patients identified; Euroscore II 1.3% [0.6%-2%]
- Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.
Statistical analysis
- Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test.
- The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.
- ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.
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
- •Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)
- •Patients undergoing transcatheter mitral valve repair with MitraClip implantation
- •Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019
排除标准
- •Patients underwent mitral valve replacement with prosthesis
- •Cardiac surgery patients not eligible for mitral valve surgery
- •Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)
结局指标
主要结局
Euroscore II predictive power for surgery
时间窗: 30 days postop
Euroscore II overall predictive power
时间窗: 30 days postop
Euroscore II predictive power for transcatheter
时间窗: 30 days postop
次要结局
未报告次要终点
研究者
Michele De Bonis
Chief of Cardiac Surgery of Advanced and Research Therapies
Ospedale San Raffaele
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous NephropathyMEMBRANOUS NEPHROPATHYNCT01955187Hospital Universitario 12 de Octubre86
进行中(未招募)
不适用
Physical Performance Testing and Frailty in Prediction of Early Postoperative Course After Cardiac SurgeryCardiac SurgeryRehabilitationFrailtyPhysical PerformanceNCT05166863Jan Gofus, MD, PhD200
已完成
不适用
EuroSCORE-II and POSPOM in Cardiac SurgeryCardiac DiseaseCardiovascular DiseasesCardiovascular ComplicationAnesthesiaPerioperative/Postoperative ComplicationsSurgeryNCT06770738Istanbul University - Cerrahpasa320
已完成
不适用
European Surgical Outcomes StudyNon-cardiac SurgeryNCT01203605Queen Mary University of London46,985
已完成
1 期
Evaluation of EYS606 in Patients With Non-infectious Posterior, Intermediate or PanuveitisNon-infectious UveitisNCT03308045Eyevensys15
