Clinical Trial: Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Brief Summary: This purpose of this study is to examine the relationship between HMGB-1 and postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based cardiac rehabilitation program.
Detailed Summary:
Exercise-based Cardiac Rehabilitation after acute myocardial infarction (AMI) has beneficial effects on cardiovascular functional capacity, quality of life, risk factors modification, and morbidity and mortality. Mounting evidences suggest that inflammation plays a key role both on initiation and progression of atherosclerosis. Several markers of systemic inflammation appear to be active effectors in the pathophysiology of athero-thrombotic disease leading to the occurrence of AMI.
The high mobility group box 1 (HMGB-1) is a ubiquitous nuclear protein constitutively expressed in quiescent cells, and it has been implicated in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB-1 has been recently recognized as a critical mediator of inflammatory diseases. In fact, the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. Specifically, HMGB-1 binds to the receptor for advanced glycation end products (RAGE) and, in turns, it activates mitogen-activated protein-kinase (MAPK) and nuclear factor-κB (NF-κB).
This intracellular pathway leads to the production of several pro-inflammatory cytokines. Interestingly, increased levels of HMGB-1 have been observed in atherosclerotic lesions, suggesting that HMGB-1 might be involved in the pathophysiology of atherosclerosis.
This study was designed to investigate the relationship between HMGB-1 and strong postinfarction predictors of outcome such as cardiopulmonary and echocardiographic parameters before and after a 6-month exercise-based Cardiac Rehabilitation program.
Sponsor: Federico II University
Current Primary Outcome: High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months [ Time Frame: baseline and 6-month follow-up ]
Original Primary Outcome: Evidence of statistically significant changes in HMGB-1 levels [ Time Frame: 6-month exercise-based Cardiac Rehabilitation program ]
Current Secondary Outcome: Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months [ Time Frame: Baseline and 6-month follow-up ]
Original Secondary Outcome: Cardiopulmonary Functional Capacity, Autonomic Function, Echocardiographic parameters, Metabolic and Cardiovascular Risk Factors Profile [ Time Frame: 6-month exercise-based Cardiac Rehabilitation program ]
Information By: Federico II University
Dates:
Date Received: September 17, 2008
Date Started: September 2008
Date Completion:
Last Updated: January 25, 2010
Last Verified: December 2009
