Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction - Full Text View

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00755131

Purpose

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.

Condition	Intervention
Acute Myocardial Infarction	Other: Exercise-based Cardiac Rehabilitation

MedlinePlus related topics: Exercise and Physical Fitness Heart Attack Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction

Further study details as provided by Federico II University:

Primary Outcome Measures:

Evidence of statistically significant changes in HMGB-1 levels [ Time Frame: 6-month exercise-based Cardiac Rehabilitation program ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiopulmonary Functional Capacity, Autonomic Function, Echocardiographic parameters, Metabolic and Cardiovascular Risk Factors Profile [ Time Frame: 6-month exercise-based Cardiac Rehabilitation program ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program	Other: Exercise-based Cardiac Rehabilitation 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.
B: No Intervention

Arms

Assigned Interventions

A: Experimental

Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program

Other: Exercise-based Cardiac Rehabilitation

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.

B: No Intervention

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

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755131

Contacts

Contact: Carlo Vigorito, M.D.	+39-81-746 ext 2639	vigorito@unina.it
Contact: Francesco Giallauria, M.D.; Ph.D.	+39-81-746 ext 3676	giallauria@libero.it

Locations

Italy
University of Naples "Federico II"	Recruiting
Naples, Italy, 80131
Contact: Carlo Vigorito, M.D. +39-81-746 ext 2639 vigorito@unina.it
Contact: Francesco Giallauria, M.D.; Ph.D. +39-81-746 ext 3676 giallauria@libero.it
Principal Investigator: Carlo Vigorito, M.D.

Sponsors and Collaborators

Federico II University

Investigators

Study Director:

Carlo Vigorito, M.D.

University of Naples "Federico II"

More Information

Publications:

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.

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. 2008 Aug 2; [Epub ahead of print]

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.

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.

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.

Cirillo P, Golino P, Calabrò P, Calì 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.

Cirillo P, Calì G, Golino P, Calabrò 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. Epub 2004 Jun 1.

Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. Review.

Yamada S, Maruyama I. HMGB1, a novel inflammatory cytokine. Clin Chim Acta. 2007 Jan;375(1-2):36-42. Epub 2006 Jul 25. Review.

Responsible Party:	Department of Clinical Medicine, Cardiovascular and Immunological Sciences ( Carlo Vigorito )
Study ID Numbers:	UNINA-15775
Study First Received:	September 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00755131
Health Authority:	Italy: National Institute of Health

Keywords provided by Federico II University:

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

Study placed in the following topic categories:

Necrosis
Heart Diseases
Dilatation, Pathologic
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009