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

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00755131
First received: September 17, 2008
Last updated: January 25, 2010
Last verified: December 2009
History of Changes

September 17, 2008
January 25, 2010
September 2008
June 2009   (final data collection date for primary outcome measure)
High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months [ Time Frame: baseline and 6-month follow-up ] [ Designated as safety issue: No ]
Evidence of statistically significant changes in HMGB-1 levels [ Time Frame: 6-month exercise-based Cardiac Rehabilitation program ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00755131 on ClinicalTrials.gov Archive Site
Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months [ Time Frame: Baseline and 6-month follow-up ] [ Designated as safety issue: No ]
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 ]
Not Provided
Not Provided
 
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Acute Myocardial Infarction
Other: Exercise-based Cardiac Rehabilitation program
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 Name: Cardiac Rehabilitation
  • Experimental: Training Group
    Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program
    Intervention: Other: Exercise-based Cardiac Rehabilitation program
  • No Intervention: Control Group
    Postinfarction patients NOT undergoing 6-months exercise-based Cardiac Rehabilitation program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
October 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00755131
UNINA-15775
No
Carlo Vigorito, Department of Clinical Medicine, Cardiovascular and Immunological Sciences
Federico II University
Not Provided
Study Director: Carlo Vigorito, M.D. Federico II University
Federico II University
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP