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Organized by
Nanjing Heart Center
Asian Bifurcation Club (ABC)
Nanjing First Hospital, Nanjing Medical University
Co-organized by
Chinese Society of Cardiology (CSC)
Capacity Building and Continuing Education Center,National Health and Family Planning Commission (CBCEC)
American Society for Cardiovascular Angiography and Interventions (SCAI)
Asian Heart Society (AHS)
Contact Us
Registration Administration of Domestic Representatives
Hongjuan Peng :
+86-13913895477
Haimei Xu +86-13914736846
cbsnj@cbsmd.cn
Registration Administration of Overseas Representatives
Ling Lin : +86 (25) 52271398
+86-13951884596
cbs@cbsmd.cn
Management of Challenging Cases
Yingying Zhao :+86-13815408517
sub@cbsmd.cn
Address
CBS2019 Congress Secretariat, Nanjing First Hospital, Building No.9 68# Changle Road, Nanjing, China
210006
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Research Paper
> Acute Coronary Syndrom
> ASCVD Prevention
> Bifurcation Stenting
> Cardio-Oncology
> Congestive Heart Failure
> DAPT Duration
> Drug Coated Balloon
> Fractional Flow Reserve
> IVUS Guidance
> Optical Coherence Tomography
> Pulmonary Hypertension
> Rotational Atherectomy
> Shear Stress
> Stenting Left Main
> Transcatheter Aortic Valve Replacement
> Percutaneous LAA Occlusion
> Mitral/Tricuspid Valvular Disease
> Other Relevant Articles
Recommended Paper
Management of Acute Myocardial Infarction During the COVID-19 Pandemic
COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-up
CSC Expert Consensus on Principles of Clinical Management of Patients with Severe Emergent Cardiovascular Diseases during the COVID-19 Epidemic
ACC Clinical Bulletin Focuses on Cardiac Implications of Coronavirus (COVID-19)
文献导读
Original Research
JOURNAL：CBSMD Article Link
CBSMD Keywords: cardivascular system; clinical study; trial design
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。
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