Challenges in the conduct of randomised controlled trials in cardiogenic shock complicating acute myocardial infarction
Anne Freund1
Steffen Desch1
Holger Thiele2
1.Department of Internal Medicine/Cardiology,Heart Center Leipzig at the University of Leipzig,Leipzig,Germany;German Center for Cardiovascular Research(DZHK),Berlin,Deutschland2.Department of Internal Medicine/Cardiology,Heart Center Leipzig at the University of Leipzig,Leipzig,Germany
摘要：Cardiogenic shock (CS) following acute myocardial infarction (AMI) is a major challenge in cardiovascular care. Mortality remains high with 40％?50％ after thirty days. Randomised controlled trials (RCTs) play a key role to generate evidence on optimal care in this field. However, the number of completed or ongoing RCTs is still relatively low compared to the gaps in evidence. Challenges in the conduct of these trials are in particular the selection of patients and ethical issues in the informed con-sent process. When determining eligibility criteria, special attention should be paid to the severity of CS, to the inclusion of pa-tients with cardiac arrest and to potential age limits. Median age of AMI-CS patients is increasing. Age limits are therefore contro-versial as it is important to include elderly patients in RCTs in order to make the results generalisable and to address the special needs of this group. As patients with AMI-CS are in most cases unable to provide informed consent themselves, a step-wise ap-proach with acute consent by a legal representative or independent physicians and later informed consent by the patient if pos-sible might be established depending on regularities of the respective ethical review board and country legislation. Multicenter studies should be sought to generate adequate power.
机标关键词：acutecardiogenicchallengescomplicatingconductcontrolledinfarctionmyocardial
论文发表日期：2022-02-28
在线出版日期：2025-08-15（本平台首次上网日期，不代表文献的发表时间）
页数：5( 125-129 )