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Completed

NCT Number: NCT00755131

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.

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Key information

Conditions

Acute Myocardial Infarction Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Remodeling

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples "Federico II"

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Cardiac Rehabilitation

Primary outcomes

  1. High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months

    Time frame: baseline and 6-month follow-up

    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.

Secondary outcomes

  1. Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months

    Time frame: Baseline and 6-month follow-up

    Oxygen consumption at peak exercise stress testing (VO2peak) was obtained breath-by-breath with use of a computerized metabolic cart. VO2peak was recorded as the mean value of VO2 during the last 20 s of the test and expressed in millilitres per kilogram per minute.

Other outcomes

  1. Heart Rate Recovery at Baseline and 6 Months

    Time frame: baseline and 6 month follow-up

    The autonomic nervous system (ANS) is the part of the peripheral nervous system that acts as a control system functioning largely below the level of consciousness, and controls visceral functions. It is subdivided into two subsystems: the parasympathetic (vagal) and sympathetic nervous system.

    Sympatho-vagal imbalance is evaluated by post-exercise Heart Rate Recovery (HRR), defined as the fall in heart rate during the first minute after exercise (beats/min). HRR is a marker of vagal tone which is a powerful predictor of all-cause mortality in patients with coronary artery disease.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2008
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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