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Published on: June 12, 2021
Challenges in the conduct of randomised controlled trials in cardiogenic shock complicating acute myocardial
Anne Freund1,2, Steffen Desch1,2, Holger Thiele1
1Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig, Leipzig, Germany.
Insights
Cardiogenic shock (CS) after acute myocardial infarction (AMI) has high mortality. Improving evidence through more randomized controlled trials (RCTs) requires addressing patient selection and informed consent challenges, especially for elderly individuals.
Area of Science:
- Cardiology
- Clinical Trials
- Critical Care Medicine
Background:
- Cardiogenic shock (CS) following acute myocardial infarction (AMI) presents a significant clinical challenge with high 30-day mortality rates (40-50%).
- Randomized controlled trials (RCTs) are crucial for advancing evidence-based care for AMI-CS, yet the number of completed or ongoing trials remains insufficient to address existing knowledge gaps.
Purpose of the Study:
- To highlight the critical need for more high-quality RCTs in cardiogenic shock following acute myocardial infarction.
- To identify and discuss key challenges in conducting RCTs for AMI-CS, focusing on patient selection and ethical considerations in informed consent.
Main Methods:
- Discussion of challenges in patient selection for AMI-CS RCTs, including severity of shock, cardiac arrest inclusion, and age limits.
- Exploration of ethical issues related to informed consent in critically ill patients, proposing a step-wise consent approach.
- Emphasis on the necessity of multicenter studies to achieve adequate statistical power.
Main Results:
- High mortality rates persist for cardiogenic shock post-acute myocardial infarction, underscoring the need for improved treatment strategies.
- Significant barriers exist in recruiting and consenting patients for clinical trials in this population.
- The median age of AMI-CS patients is increasing, necessitating the inclusion of elderly individuals in trials for generalizability.
Conclusions:
- Further multicenter randomized controlled trials are essential to improve outcomes for patients with cardiogenic shock following acute myocardial infarction.
- Careful consideration of eligibility criteria, including age and severity, and innovative approaches to informed consent are vital for successful trial conduct.
- Addressing these challenges will enhance the evidence base and ultimately improve the management of this high-risk patient group.
Abstract:
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 consent process. When determining eligibility criteria, special attention should be paid to the severity of CS, to the inclusion of patients with cardiac arrest and to potential age limits. Median age of AMI-CS patients is increasing. Age limits are therefore controversial 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 approach with acute consent by a legal representative or independent physicians and later informed consent by the patient if possible might be established depending on regularities of the respective ethical review board and country legislation. Multicenter studies should be sought to generate adequate power.
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