Design and Rationale of the EARMI Trial: A Randomized Controlled Trial on Early-Phase Cardiac Rehabilitation
Kaiyuan Cen1,2,3, Fatimah Ahmedy4,5, Mexmollen Marcus6
1Cardiovascular Department, Guidong People's Hospital of Guangxi Zhuang Autonomous Region, Wuzhou, China, cky163163@163.com.
Insights
This study investigates early, structured cardiac rehabilitation (CR) for acute myocardial infarction (AMI) patients post-percutaneous coronary intervention (PCI). Findings may guide timely CR integration for improved recovery and cardiovascular care.
Area of Science:
- Cardiology
- Cardiovascular Rehabilitation
- Clinical Trials
Background:
- Cardiac rehabilitation (CR) is vital for secondary prevention in coronary artery disease.
- Optimal timing, structure, and feasibility of early in-hospital CR post-acute myocardial infarction (AMI) with percutaneous coronary intervention (PCI) require further investigation.
Purpose of the Study:
- To assess the efficacy and safety of a structured, phase-specific CR program initiated within 24 hours post-PCI in AMI patients.
- To evaluate the impact of early CR on left ventricular function, exercise capacity, and autonomic function.
Main Methods:
- The EARMI trial is a multicenter, randomized controlled trial involving 80 AMI patients randomized to early CR or usual care.
- The CR program includes progressive aerobic and resistance training across ICU, hospital ward, and home-based phases.
- Primary outcomes include left ventricular ejection fraction (LVEF), exercise capacity (VO2 peak), and heart rate variability (HRV).
Main Results:
- The study is powered to detect significant improvements in myocardial function, exercise tolerance, and autonomic regulation over 12 weeks.
- Safety and feasibility will be assessed via adverse event monitoring and adherence rates.
Conclusions:
- The EARMI trial is pioneering in evaluating early-phase CR initiation during the acute phase of AMI.
- Results may offer insights into scalable, time-sensitive rehabilitation strategies for post-AMI recovery and cardiovascular care pathways.
Introduction:
Cardiac rehabilitation (CR) is a key component of secondary prevention in patients with coronary artery disease. However, the optimal timing, structure, and feasibility of exercise-based cardiac rehabilitation initiated during hospitalization following acute myocardial infarction (AMI) treated with percutaneous coronary intervention (PCI) remain underexplored.
Methods:
The EARMI trial is a multicenter, randomized, parallel-group controlled trial designed to assess the efficacy and safety of a structured, phase-specific CR program initiated within 24 h post-PCI. This intervention will be implemented across three distinct recovery phases: intensive care unit, hospital ward, and home-based rehabilitation. Eighty AMI patients will be randomized (1:1) to receive exercise-based CR or usual care. The intervention consists of progressive aerobic and resistance training, with individualized progression tailored to each patient's clinical status. The primary outcomes include left ventricular function (measured by left ventricular ejection fraction, LVEDD, LVESD), exercise capacity (assessed by VO2 peak, 6MWT, and METs), and autonomic function (evaluated by heart rate variability [HRV]). Secondary outcomes include health-related quality of life (assessed by SF-36), metabolic markers, and major adverse cardiovascular events. Over the 12 weeks intervention period, the study is powered to detect clinically significant improvements in myocardial function, exercise tolerance, and autonomic regulation. Safety and feasibility will be assessed through continuous surveillance of adverse events and quantification of adherence rates.
Conclusion:
The EARMI trial is one of the first studies to evaluate the impact of initiating a structured early-phase CR model during the acute phase of AMI. The findings may provide crucial insights into scalable, time-sensitive rehabilitation strategies for post-AMI recovery and contribute to the integration of CR into modern cardiovascular care pathways.
