Background: High-mobility group box-1 (HMGB1) is a ubiquitous nuclear protein recently recognized as a critical mediator of inflammatory processes. HMGB1 is a novel predictor of adverse postinfarction clinical outcomes, playing a crucial role in the appropriate healing process after myocardial infarction (MI). The present trial is designed in order to reveal the postinfarction HMGB1 expression pattern and its relationship with cardiac remodeling. The effects of an exercise-based cardiac rehabilitation program on HMGB1 expression pattern will be addressed as well.
Design: Single-center, randomized, controlled study carried out at a university hospital.
Methods: Postinfarction patients are randomized into a training group (enrolled in a 6-month exercise-based cardiac rehabilitation program) and into a control group. HMGB1 levels are evaluated by enzyme-linked immunosorbent assay.
Results: Postinfarction patients are enrolled from September 2008 through December 2009. Results will be available in mid-2010.
Conclusion: Despite the importance of the inflammatory response and healing process in postinfarction left ventricular remodeling, the mechanisms that initiate and control these processes remain to be elucidated. The rationale and design of the present study is designed to test the postinfarction HMGB1 expression pattern and its relationship with cardiac remodeling as well as the effects of an exercise-based cardiac rehabilitation program.
Trial registration: ClinicalTrials.gov NCT00755131.