On October 5, 2025, Beijing Anzhen Hospital announced its study, evaluating mild therapeutic hypothermia (MTH) as part of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) receiving venous-arterial extracorporeal membrane oxygenation (VA-ECMO). The study, currently listed as not yet recruiting, highlights a novel therapeutic approach for managing a critical patient population. Clinical teams, regulatory professionals, and quality teams may wish to follow developments on this trial closely.
In this article:
- What changed?
- Study objectives
- Eligibility and scope
- Potential impact
- FAQ
- Conclusion
- Disclaimer
- Link to full study details
What changed?
Beijing Anzhen Hospital unveiled its plans for a clinical trial focusing on MTH as an adjunctive therapy during PCI for AMICS. The methodology includes leveraging VA-ECMO to support patients undergoing the procedure. Mild therapeutic hypothermia has been proposed as a way to minimize ischemic injury, yet evidence remains sparse on its integrated use within this specific clinical scenario. This study aims to fill those gaps.
Study objectives
The primary objective is to evaluate the safety and potential efficacy of mild therapeutic hypothermia applied during PCI in patients receiving VA-ECMO due to AMICS. Researchers hope to determine whether temperature modulation can improve patient outcomes by reducing myocardial injury and increasing recovery chances. Secondary goals include collecting data to inform future device methodologies and protocols.
Why focus on hypothermia?
Mild therapeutic hypothermia has demonstrated effectiveness in other areas such as cardiac arrest recovery. Its use in invasive cardiac interventions supported by VA-ECMO systems could represent a shift in treating severe myocardial damage compounded by shock. By directly targeting temperature management during PCI, the trial seeks to address multiple physiological disruptions simultaneously.
Eligibility and scope
The study specifies patients diagnosed with AMICS requiring VA-ECMO as the target population. Techniques such as MTH during PCI could offer additional benefits in stabilizing outcomes for this critical demographic. However, patient inclusion remains pending formal recruitment procedures, and suitable candidates will undergo rigorous eligibility assessments for compliance with the trial protocols.
Not yet recruiting
As of the publication date, the trial remains in the preparatory phase and is currently marked as “Not yet recruiting.” Interested institutions or participants are encouraged to monitor updates for recruitment timelines.
Potential impact
Incorporating mild therapeutic hypothermia into PCI processes for cardiogenic shock patients on VA-ECMO could redefine treatment paradigms. Success in this trial may lead to device optimization and improved procedural frameworks. For manufacturers, clinical findings may also contribute to shaping regulatory pathways for new medical devices leveraging temperature modulation technology.
Implications for regulatory teams
Regulatory professionals should monitor this trial closely as it explores interactions between therapeutic hypothermia and VA-ECMO systems. Data generated here could inform safety assessments and performance benchmarks critical to future device approvals. Collaboration with institutional sponsors and clinicians will likely be pivotal.
FAQ
- Who sponsors the study?
The study is sponsored by Beijing Anzhen Hospital. - What conditions does the trial address?
The trial specifically targets acute myocardial infarction complicated by cardiogenic shock (AMICS). - What intervention will be studied?
Mild therapeutic hypothermia during PCI supported by VA-ECMO. - When will recruitment begin?
Recruitment timelines are yet to be announced as the trial is currently listed as not yet recruiting.
Conclusion
The evaluation of mild therapeutic hypothermia in PCI for AMICS supported by VA-ECMO represents a groundbreaking approach in cardiac care. Clinical, quality, and regulatory teams should track progress closely to utilize findings effectively. Such advancements have the potential to guide future device development and regulatory strategies.
Disclaimer
This blog is intended for informational purposes only and does not constitute legal or clinical advice. For specific guidance, consult regulatory experts or medical professionals.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07186972?term=medical+device