Rationale and Design of a Randomised Proof-of-Concept Trial to Assess the Safety of Early Discharge Using Index
Muntaser Omari1,2, Mohamed Ali1, Luke Spray1
1Cardiothoracic Centre, Freeman Hospital, Newcastle-upon-Tyne NE7 7DN, UK.
Insights
The SECURE study explores using the Index of Microcirculatory Resistance (IMR) to safely discharge low-risk acute myocardial infarction patients within 24 hours after primary percutaneous coronary intervention (PPCI). This approach aims for personalized, early hospital release.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Current guidelines suggest 48-72h hospital stay post-primary percutaneous coronary intervention (PPCI) for low-risk patients.
- Recent evidence supports very early discharge (within 24h) after uncomplicated PPCI in selected patients.
- Objective tools to guide very early discharge timing are limited.
Purpose of the Study:
- To evaluate the feasibility of using the Index of Microcirculatory Resistance (IMR) to guide very early discharge (within 24h) after PPCI.
- To assess if low IMR identifies patients suitable for safe, rapid hospital discharge.
- To provide proof-of-concept data for a personalized discharge strategy.
Main Methods:
- Prospective, randomized, open-label, single-centre trial (SECURE study).
- Recruitment of 82 low IMR patients following successful PPCI.
- Randomization to standard discharge or very early discharge (within 24h) with IMR guidance.
- Assessment of left ventricle ejection fraction via cardiac MRI and 3-month telephone follow-up.
Main Results:
- This section is not applicable as the study is a proof-of-concept trial and results are not yet available.
Conclusions:
- The SECURE study will provide initial data on the feasibility of using IMR to guide very early discharge post-PPCI.
- Successful outcomes could support planning for a larger trial to confirm the safety of this personalized approach.
- This research may lead to optimized hospital length of stay protocols for acute myocardial infarction patients.
Abstract:
Background: Current guidelines acknowledge that early discharge is not associated with late mortality and that in-hospital length of stay (LOS) of 48-72 h should be considered following successful primary percutaneous coronary intervention (PPCI) in low-risk patients. Recent studies have highlighted the safety of very early discharge after PPCI in highly selected low-risk patients; however, objective tools to guide discharge timing remain limited. The Index of Microcirculatory Resistance (IMR) offers a quantitative assessment of microvascular function and may help identify patients suitable for very early discharge. We aimed to evaluate the feasibility of using IMR to guide very early discharge in patients who underwent uncomplicated PPCI. Study design and objectives: The Safety of Early Discharge Using Index Microcirculatory Resistance in Patients with Acute Myocardial Infarction (SECURE) study is designed to assess the feasibility of using IMR, measured immediately following successful PPCI, to guide early discharge from hospital within 24 h. The SECURE study is a prospective, proof-of-concept, functional non-inferiority, single-centre, randomised, open-label trial to determine if patients with low IMR can be safely discharged when compared to standard discharge policy. The SECURE study will recruit 82 patients with low IMR following successful PPCI. Participants will be 1:1 randomised to either standard discharge timing or very early discharge (within 24 h). The left ventricle ejection fraction will be assessed using cardiac magnetic resonance imaging. A telephone follow-up at 3 months will be arranged. Clinical events are collected as secondary and exploratory safety endpoints. Conclusions: The SECURE study will provide proof-of-concept data about the feasibility of using IMR to guide very early discharge following PPCI. If successful, this study will provide data to plan for a larger study to determine the safety of this personalised approach.
