CBS 2019
CBSMD教育中心
English

科学研究

科研文章

荐读文献

ACC/AATS/AHA/ASE/ASNC/HRS/SCAI/SCCT/SCMR/STS 2019 Appropriate Use Criteria for Multimodality Imaging in the Assessment of Cardiac Structure and Function in Nonvalvular Heart Disease: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and the Society of Thoracic Surgeons A Novel Familial Cardiac Arrhythmia Syndrome with Widespread ST-Segment Depression Screening for Cardiovascular Disease Risk With Electrocardiography: US Preventive Services Task Force Recommendation Statement Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study) Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention: A Consensus Document From the Academic Research Consortium for High Bleeding Risk Sudden Cardiac Arrest Survivorship: A Scientific Statement From the American Heart Association Management of No-Reflow Phenomenon in the Catheterization Laboratory Digital learning and the future cardiologist Residual Inflammatory Risk in Patients With Low LDL Cholesterol Levels Undergoing Percutaneous Coronary Intervention Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status - Results from the EMPEROR-Reduced Trial
|<<... 56 57 58 59 60 61 62 ...>>|

Original Research

JOURNAL：CBSMD Article Link

心脏代谢临床试验中的黑洞 —— 不明原因死亡

CBSMD Keywords: cardivascular system; clinical study; trial design

Pre-reading

现代心脏代谢临床试验常将心血管死亡作为主要研究复合终点事件的一部分，由临床事件委员会（clinical event committees， CEC）明确死因。因可掌握信息不充分而无法判定死因的情况时有发生，属于临床试验终点事件的黑洞区域。 US FDA对经营管理好的临床试验的其中一项评价标准是无法明确死因的发生率应控制在罕见范围，而现实并非如此。“Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials”对9项心脏代谢临床试验的死亡原因进行了汇总分析，评估其中不明原因死亡（undetermined death）的发生率。


同期发表在《循环》上的评论文章“Classification of Deaths in Cardiovascular Outcomes Trials”

1. 介绍了心脏代谢临床试验将死亡分为心源性死亡及非心源性死亡这一通用做法的原因；

2. 指出在使用随机、对照、设盲临床设计评估新疗法有效性和安全性的同时，虽然可能的试验偏差可通过好的试验设计得以有效的规避，但对那些已知范围外未知的把控也体现了一项优质临床试验的科研质控水平。

3. 罗列了不同试验操作系统中导致无法判定死因的数量产生变化的三种情形：
(1)    完整记录缺失或死亡判定原因不充分；
(2)    死亡过程不可知(例如独居者死亡时间不确定且未经尸检明确)；
(3)    研究人员获得完整数据受限(例如随访知情同意撤回)。
4. 建议可通过加大对不明原因死亡事件的管理，进一步提高未来临床试验的数据质量，才能有效地通过试验得出心血管疗法是否确为安全或有效。


>CBS CBS 2019

> CBS 2019

> CBS 2019 注册

> CBS 2019 会议日程

> CBS 2019 学术征集

> CBS 2019 热点

 CBSMD

> CBSMD 网站注册

> 教育中心

> 荐读文献

> Top 10 阅读文献

> 文献导读
CBS 2019 CBS 2019 主席团 教育中心 科研动态
Copyright ⓒ CBS MD Nanjing China. All rights reserved. 京ICP备16025898号-11
联系我们| Top