Clinical trial NCT00755131: Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Official title: Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Cardiac Rehabilitation
High Mobility Group Box proteins
Inflammatory markers
Cardiopulmonary Functional Capacity
Maximal Oxygen Consumption
Echocardiography
Left Ventricular Ejection Fraction
Left Ventricular Chambers Dilation
Left Ventricular Remodeling
Left Atrium Remodeling
Cardiac Remodeling
Exercise Training
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2008-09-18
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Acute Myocardial Infarction

Exclusion Criteria:

* BMI higher than 30 and lower than 18
* Residual myocardial ischemia
* Severe ventricular arrhythmias
* IIb or III degree atrio-ventricular block
* Valvular disease requiring surgery
* Pericarditis
* Severe renal dysfunction (i.e. creatinine \>2.5 mg/dl)
* Severe concomitant non-cardiac disease such as cancer
* Liver dysfunction (alanine aminotransferase/aspartate aminotransferase level \>1.5 times the upper normal limit)
* Dementia
* Any systemic disease limiting exercise
* Inability to participate in a prospective study for any logistic reason

Primary outcomes:
measure: High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months
timeFrame: baseline and 6-month follow-up
Secondary outcomes:
measure: Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months
timeFrame: Baseline and 6-month follow-up
Other outcomes:
measure: Heart Rate Recovery at Baseline and 6 Months
timeFrame: baseline and 6 month follow-up
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Carlo Vigorito, M.D.
role: STUDY_DIRECTOR
References:
citation: Giallauria F, Cirillo P, Lucci R, Pacileo M, De Lorenzo A, D'Agostino M, Moschella S, Psaroudaki M, Del Forno D, Orio F, Vitale DF, Chiariello M, Vigorito C. Left ventricular remodelling in patients with moderate systolic dysfunction after myocardial infarction: favourable effects of exercise training and predictive role of N-terminal pro-brain natriuretic peptide. Eur J Cardiovasc Prev Rehabil. 2008 Feb;15(1):113-8. doi: 10.1097/HJR.0b013e3282f00990.
citation: Giallauria F, Galizia G, Lucci R, D'Agostino M, Vitelli A, Maresca L, Orio F, Vigorito C. Favourable effects of exercise-based Cardiac Rehabilitation after acute myocardial infarction on left atrial remodeling. Int J Cardiol. 2009 Aug 21;136(3):300-6. doi: 10.1016/j.ijcard.2008.05.026. Epub 2008 Aug 3.
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citation: Giallauria F, Cirillo P, Lucci R, Pacileo M, D'agostino M, Maietta P, Vitelli A, Chiariello M, Vigorito C. Effects of exercise-based cardiac rehabilitation on high mobility group box-1 levels after acute myocardial infarction: rationale and design. J Cardiovasc Med (Hagerstown). 2009 Aug;10(8):659-63. doi: 10.2459/JCM.0b013e32832d4979.
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