- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00755131
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Naples, Italy, 80131
- University of Naples "Federico II"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Training Group
Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program
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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.
Other Names:
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No Intervention: Control Group
Postinfarction patients NOT undergoing 6-months exercise-based Cardiac Rehabilitation program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months
Time Frame: baseline and 6-month follow-up
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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.
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baseline and 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months
Time Frame: Baseline and 6-month follow-up
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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.
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Baseline and 6-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Recovery at Baseline and 6 Months
Time Frame: baseline and 6 month follow-up
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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. |
baseline and 6 month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Carlo Vigorito, M.D., Federico II University
Publications and helpful links
General Publications
- Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Exercise Training
- Inflammatory markers
- Echocardiography
- Cardiac Rehabilitation
- Maximal Oxygen Consumption
- Left Ventricular Remodeling
- Left Ventricular Ejection Fraction
- Cardiac Remodeling
- High Mobility Group Box proteins
- Cardiopulmonary Functional Capacity
- Left Ventricular Chambers Dilation
- Left Atrium Remodeling
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNINA-15775
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