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IRCT201102283449N5 IRCT 2011-08-01 Tehran University of Medical Sciences Determining NAC mechanism in the prevention of early remodeling Determining the mechanism of N-acetylcysteine in the prevention of early remodeling, role of oxidative stress 2010-08-01 anticipated 80 Complete https://irct.ir/trial/3538 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention. N/A Acute Myocardial Infarction. Intervention 1: Intervention: NAC 600 mg BD for 3 days per oral. Intervention 2: Control: Placebo BD for 3 days per oral. Background: Ischemia following acute myocardial infarction provoked an increase in the level of main pro-fibrotic and inflammatory cytokine including transforming growth factor β (TGF-β) and tumor necrosis factor α (TNF-α) . 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-α and TGF-β levels in human subjects with AMI.<br /> 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-β and TNF-α serum levels after 24 and 72 hours of NAC or placebo administration, peripheral venous blood (10 ml) samples were collected at these time points.<br /> 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-β and TNF-α after 24 and 72 hours within NAC or placebo groups revealed that there was not any significant difference except for TGF-β levels in placebo group that increased significantly with time past (p=0.042).<br /> Conclusion: The administration of NAC could prevent TGF-β levels from increasing after 72 hours as compared with those received placebo. As TGF-β had strong correlations with the ejection fraction as the marker of LV systolic function its late antagonism seems to be important. <br />
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scientific Hossein Khalili
Tehran University of Medical Sciences, Enghelab Ave
Tehran Iran (Islamic Republic of) +98 21 6695 4715 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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. no limit no limit Both I21 Acute Myocardial Infarction Prevention Prevention Intervention: NAC 600 mg BD for 3 days per oral Control: Placebo BD for 3 days per oral Tumor necrosis factor-alpha. Timepoint: 24 and 72 hours after administration of NAC or Placebo. Method of measurement: Elisa. Transforming growth factor-beta. Timepoint: 24 and 72 hours after administration of NAC or Placebo. Method of measurement: Elisa. Tehran University of Medical Sciences Approved 2011-07-23 Tehran University of Medical Sciences Tehtan University of Medical Sciences, Enghelab Ave Tehran Iran (Islamic Republic of)