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

NCT00755131 | Completed Results

• 1 other identifier: UNINA-15775
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months

  Baseline and 6-month follow-up

Other Outcomes (1)

• Heart Rate Recovery at Baseline and 6 Months

  baseline and 6 month follow-up

Study Arms (2)

Training Group

EXPERIMENTAL

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

Other: Exercise-based Cardiac Rehabilitation program

Control Group

NO INTERVENTION

Postinfarction patients NOT undergoing 6-months exercise-based Cardiac Rehabilitation program

Interventions

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.

Also known as: Cardiac Rehabilitation

Training Group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute Myocardial Infarction

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80131, Italy

Location

Related Publications (12)

• 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.

  PMID: 18277196 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.

  PMID: 18676038 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.

  PMID: 16874155 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.

  PMID: 16874143 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.

  PMID: 16870634 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.

  PMID: 16023093 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.

  PMID: 15173027 BACKGROUND

• Libby P, Ridker PM, Maseri A. Inflammation and atherosclerosis. Circulation. 2002 Mar 5;105(9):1135-43. doi: 10.1161/hc0902.104353.

  PMID: 11877368 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.

  PMID: 16979611 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.

  PMID: 19651408 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.

  PMID: 19451831 BACKGROUND

• 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.

  PMID: 21300299 DERIVED

MeSH Terms

Conditions

Ventricular Remodeling

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Prof. Carlo Vigorito, Director Cardiac Rehabilitation Unit, Federico II University
• Organization: University of Naples Federico II

vigorito@unina.it

+39081746

Study Officials

• Carlo Vigorito, M.D.

  Federico II University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 2, 2010
• Results First Posted: January 25, 2010

Record last verified: 2009-12

Locations

IT (1)