Effects of Cardiac Rehabilitation on High Mobility Group Box-1 Levels After Acute Myocardial Infarction
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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 |
- 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 ]
- 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 |
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 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 May 21, 2013