Impact of cardiac rehabilitation programs on left ventricular remodeling after acute myocardial infarction: Study Protocol Clinical Trial (SPIRIT Compliant)

INTRODUCTION: While the role of early mobilization in the immediate postinfarction period has been well demonstrated, little is known in present about the link between early mobilization and reduction of systemic inflammation. At the same time, the impact of early mobilization on regression of left ventricular remodeling has not been elucidated so far. MATERIAL AND METHODS: Here we present the study protocol of the REHAB trial, a clinical descriptive, prospective study, conducted in a single-center, with the purpose to analyze the impact of early mobilization in reducing left ventricular remodeling, the complication rates and mortality in patients who had suffered a recent acute myocardial infarction (AMI). At the same time, the study aims to demonstrate the contribution of early mobilization to reduction of systemic inflammation, thus reducing the inflammation-mediated ventricular remodeling. 100 patients with AMI in the last 12 hours, and successful revascularization of the culprit artery within the first 12 hours after the onset of symptoms in ST-segment elevation acute myocardial infarction or within first 48 hours in non ST-segment elevation AMI will be enrolled in the study. Based on the moment of mobilization after AMI patients will be distributed in 2 groups: group 1 – patients with early mobilization (<2 days after the onset of symptoms) and; group 2 – subjects with delayed mobilization after AMI (>2 days after the onset of symptoms). Study outcomes will consist in the impact of early mobilization after AMI on the ventricular remodeling in the post-infarction period, as assessed by cardiac magnetic resonance imaging, the rate of in-hospital mortality, the rate of repeated revascularization or MACE and the effect of early mobilization on systemic inflammation in the immediate postinfarction phase. CONCLUSION: In conclusion, REHAB will be the first trial that will elucidate the impact of early mobilization in the first period after AMI, as a first step of a complex cardiac rehabilitation program, to reduce systemic inflammation and prevent deleterious ventricular remodeling in patients who suffered a recent AMI.