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
  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 program

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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months [ Time Frame: Baseline and 6-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training Group
Postinfarction patients undergo 6-month exercise-based Cardiac Rehabilitation Program
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
No Intervention: Control Group
Postinfarction patients NOT undergoing 6-months exercise-based Cardiac Rehabilitation program

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
University of Naples "Federico II"
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Study Director: Carlo Vigorito, M.D. Federico II University
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlo Vigorito, Department of Clinical Medicine, Cardiovascular and Immunological Sciences
ClinicalTrials.gov Identifier: NCT00755131     History of Changes
Other Study ID Numbers: UNINA-15775
Study First Received: September 17, 2008
Results First Received: November 5, 2009
Last Updated: January 25, 2010
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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014