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临床试验/IRCT201102283449N5
IRCT201102283449N5已完成未知

Determining the mechanism of N-acetylcysteine in the prevention of early remodeling, role of oxidative stress

Tehran University of Medical Sciences0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
80

研究概览

简要总结

Background: Ischemia following acute myocardial infarction provoked an increase in the level of main pro-fibrotic and inflammatory cytokine including transforming growth factor ß (TGF-ß) and tumor necrosis factor a (TNF-a) . NAC is hypothesized to have numerous therapeutic benefits in the management of cardiovascular diseases including post AMI cardiac remodeling. However, to the best of our knowledge, this is the first study evaluated NAC effect on TNF-a and TGF-ß levels in human subjects with AMI.
Method: Following confirmation of STEMI, 88patients randomly administered NAC effervescent tablet 600 mg (Fluimucil®, Zambon, Swiss) or placebo twice daily for three days. For quantification of TGF-ß and TNF-a serum levels after 24 and 72 hours of NAC or placebo administration, peripheral venous blood (10 ml) samples were collected at these time points.
Results: The comparison of biomarkers’ levels measured after 24 and 72 (hours between NAC and placebo groups did not show any statistically significant difference. The comparisons between levels of TGF-ß and TNF-a after 24 and 72 hours within NAC or placebo groups revealed that there was not any significant difference except for TGF-ß levels in placebo group that increased significantly with time past (p=0.042).
Conclusion: The administration of NAC could prevent TGF-ß levels from increasing after 72 hours as compared with those received placebo. As TGF-ß had strong correlations with the ejection fraction as the marker of LV systolic function its late antagonism seems to be important.

研究设计

研究类型
Interventional

入排标准

年龄范围
no limit 至 no limit(—)
性别
All

入选标准

  • Inclusion Criteria; Patients with criteria of first episode of ST-elevation AMI including typical chest pain with the duration of more than 30 minutes, >1-mm ST elevation in =2 adjacent limb leads or >2-mm ST elevation in =2 adjacent chest leads, and a raise in creatine kinase or in troponin T level 2 times the upper limit of normal were included in the study.
  • Exclusion Criteria; Patients with history of prior AMI, heart failure, atrial fibrillation, valvular dysfunction, and neoplastic, renal, liver, or thyroid diseases were excluded from the study. Moreover patients with current acute or chronic infections, autoimmune diseases, surgical procedures in the past 3 months; under treatment with anti-inflammatory drugs, supplements and antioxidants, subsequent MI, discharge or death during the study period were excluded.

排除标准

  • 未提供

研究者

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