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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Group | Experimental | Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program |
|
| Control Group | No Intervention | Postinfarction patients NOT undergoing 6-months exercise-based Cardiac Rehabilitation program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise-based Cardiac Rehabilitation program | Other | Trained patients attend the exercise training protocol for 6 months on hospital ambulatory-based regimen 3 times/week. Training sessions are supervised under continuous electrocardiography monitoring by a cardiologist, a physiotherapist and a graduate nurse. Each session is preceded by a 5-min warming-up and followed by a 5-min cooling-down. Exercise is performed for 30 min on a bicycle ergometer with the target of 60-70% of the peak oxygen consumption achieved at the initial symptom-limited cardiopulmonary exercise test. Exercise protocol is performed with a gradual increase in exercise workload until the achievement of the predefined target. |
| Measure | Description | Time Frame |
|---|---|---|
| High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months | High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. | baseline and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months | Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute. | Baseline and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Recovery at Baseline and 6 Months | The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system. Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Vigorito, M.D. | Federico II University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples "Federico II" | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18277196 | Background | 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. | |
| 18676038 |
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This study was a single-center, randomized, controlled study carried out from October 2008 to January 2009 at the Department of Clinical Medicine, Cardiovascular and Immunological Sciences, University of Naples "Federico II".
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Training Group | Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program |
| FG001 | Control Group | Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise Training Group | Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program |
| BG001 | Control Group | Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months | High mobility group box-1 (HMGB1) is a ubiquitous nuclear protein, constitutively expressed in quiescent cells, where it is involved in several cellular functions, including determination of nucleosomal structure and stability, and binding of transcription factors to DNA sequences. HMGB1 has been recently recognized as a critical mediator of inflammatory processes: the passive release of this protein from necrotic or damaged cells represents an effective stimulus triggering the inflammatory response. | Posted | Mean | Standard Deviation | ng/ml | baseline and 6-month follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise Training Group | Postinfarction patients undergoing 6-month exercise-based Cardiac Rehabilitation Program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Carlo Vigorito, Director Cardiac Rehabilitation Unit, Federico II University | University of Naples Federico II | +39081746 | 2639 | vigorito@unina.it |
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| ID | Term |
|---|---|
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072038 | Cardiac Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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|
|
| baseline and 6 month follow-up |
| Background |
| 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. |
| 16874155 | Background | Giallauria F, De Lorenzo A, Pilerci F, Manakos A, Lucci R, Psaroudaki M, D'Agostino M, Del Forno D, Vigorito C. Reduction of N terminal-pro-brain (B-type) natriuretic peptide levels with exercise-based cardiac rehabilitation in patients with left ventricular dysfunction after myocardial infarction. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):625-32. doi: 10.1097/01.hjr.0000209810.59831.f4. |
| 16874143 | Background | Giallauria F, De Lorenzo A, Pilerci F, Manakos A, Lucci R, Psaroudaki M, D'Agostino M, Del Forno D, Vigorito C. Long-term effects of cardiac rehabilitation on end-exercise heart rate recovery after myocardial infarction. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):544-50. doi: 10.1097/01.hjr.0000216547.07432.fb. |
| 16870634 | Background | Giallauria F, Lucci R, Pietrosante M, Gargiulo G, De Lorenzo A, D'Agostino M, Gerundo G, Abete P, Rengo F, Vigorito C. Exercise-based cardiac rehabilitation improves heart rate recovery in elderly patients after acute myocardial infarction. J Gerontol A Biol Sci Med Sci. 2006 Jul;61(7):713-7. doi: 10.1093/gerona/61.7.713. |
| 16023093 | Background | Cirillo P, Golino P, Calabro P, Cali G, Ragni M, De Rosa S, Cimmino G, Pacileo M, De Palma R, Forte L, Gargiulo A, Corigliano FG, Angri V, Spagnuolo R, Nitsch L, Chiariello M. C-reactive protein induces tissue factor expression and promotes smooth muscle and endothelial cell proliferation. Cardiovasc Res. 2005 Oct 1;68(1):47-55. doi: 10.1016/j.cardiores.2005.05.010. |
| 15173027 | Background | Cirillo P, Cali G, Golino P, Calabro P, Forte L, De Rosa S, Pacileo M, Ragni M, Scopacasa F, Nitsch L, Chiariello M. Tissue factor binding of activated factor VII triggers smooth muscle cell proliferation via extracellular signal-regulated kinase activation. Circulation. 2004 Jun 15;109(23):2911-6. doi: 10.1161/01.CIR.0000129312.43547.08. Epub 2004 Jun 1. |
| 11877368 | Background | Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353. |
| 16979611 | Background | Yamada S, Maruyama I. HMGB1, a novel inflammatory cytokine. Clin Chim Acta. 2007 Jan;375(1-2):36-42. doi: 10.1016/j.cca.2006.07.019. Epub 2006 Jul 25. |
| 19651408 | Background | Giallauria F, Cirillo P, Lucci R, Pacileo M, D'Agostino M, Maietta P, Vitelli A, Chiariello M, Vigorito C. Autonomic dysfunction is associated with high mobility group box-1 levels in patients after acute myocardial infarction. Atherosclerosis. 2010 Jan;208(1):280-4. doi: 10.1016/j.atherosclerosis.2009.07.025. Epub 2009 Jul 14. |
| 19451831 | Background | 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. |
| 21300299 | Derived | Giallauria F, Cirillo P, D'agostino M, Petrillo G, Vitelli A, Pacileo M, Angri V, Chiariello M, Vigorito C. Effects of exercise training on high-mobility group box-1 levels after acute myocardial infarction. J Card Fail. 2011 Feb;17(2):108-14. doi: 10.1016/j.cardfail.2010.09.001. Epub 2010 Oct 29. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program. |
|
|
|
| Secondary | Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months | Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute. | intention to treat (ITT) analysis | Posted | Mean | Standard Deviation | ml/kg/min | Baseline and 6-month follow-up |
|
|
|
|
| Other Pre-specified | Heart Rate Recovery at Baseline and 6 Months | The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system. Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease. | Posted | Mean | Standard Deviation | beats/min | baseline and 6 month follow-up |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Control Group | Postinfarction patients NOT enrolled in exercise-based Cardiac Rehabilitation program. | 0 | 38 | 0 | 38 |
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| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |