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临床试验/NCT00755131
NCT00755131已完成不适用

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

Federico II University2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
High Mobility Group Box-1 (HMGB1)Levels at Baseline and 6 Months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute Myocardial Infarction

排除标准

  • 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)
  • Any systemic disease limiting exercise
  • Inability to participate in a prospective study for any logistic reason

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Peak Oxygen Consumption (VO2peak) at Baseline and 6 Months(Baseline and 6-month follow-up)

研究者

发起方
Federico II University
申办方类型
Other

研究点 (2)

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