TY - JOUR
T1 - The effects of hydrogen gas inhalation on adverse left ventricular remodeling after percutaneous coronary intervention for ST-elevated myocardial infarction
T2 - First pilot study in humans
AU - Katsumata, Yoshinori
AU - Sano, Fumiya
AU - Abe, Takayuki
AU - Tamura, Tomoyoshi
AU - Fujisawa, Taishi
AU - Shiraishi, Yasuyuki
AU - Kohsaka, Shun
AU - Ueda, Ikuko
AU - Homma, Koichiro
AU - Suzuki, Masaru
AU - Okuda, Shigeo
AU - Maekawa, Yuichiro
AU - Kobayashi, Eiji
AU - Hori, Shingo
AU - Sasaki, Junichi
AU - Fukuda, Keiichi
AU - Sano, Motoaki
N1 - Publisher Copyright:
© 2017, Japanese Circulation Society. All rights reserved.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2017
Y1 - 2017
N2 - Background: Hydrogen gas inhalation (HI) reduced infarct size and mitigated adverse left ventricular (LV) remodeling in a rat model of acute myocardial infarction (AMI). We designed a prospective, open-label, rater-blinded clinical pilot study in patients experiencing ST-elevated MI (STEMI). Methods and Results: The 20 patients with an initial diagnosis of STEMI were assigned to either an HI group (1.3% H2 with 26% oxygen) or a control group (26% oxygen). There were no HI-related severe adverse events. In the full analysis set, the cardiac salvage index as evaluated using cardiac magnetic resonance imaging at 7 days after primary percutaneous coronary intervention (PCI), showed no significant between-group difference (HI: 50.0±24.3%; control: 60.1±20.1%; P=0.43). However, the improvement from day 7 in the HI group was numerically greater than that in the control group in some of the surrogate outcomes at 6-month follow-up, including the LV stroke volume index (HI: 9.2±7.1 mL/m2; control: -1.4±7.2 mL/m2; P=0.03) and the LV ejection fraction (HI: 11.0%±9.3%; control: 1.7%±8.3%; P=0.11). Conclusions: The first clinical study has shown that HI during PCI is feasible and safe and may also promote LV reverse remodeling at 6 months after STEMI. The study was not powered to test efficacy and a further large-scale trial is warranted. (Clinical trials registration: UMIN00006825).
AB - Background: Hydrogen gas inhalation (HI) reduced infarct size and mitigated adverse left ventricular (LV) remodeling in a rat model of acute myocardial infarction (AMI). We designed a prospective, open-label, rater-blinded clinical pilot study in patients experiencing ST-elevated MI (STEMI). Methods and Results: The 20 patients with an initial diagnosis of STEMI were assigned to either an HI group (1.3% H2 with 26% oxygen) or a control group (26% oxygen). There were no HI-related severe adverse events. In the full analysis set, the cardiac salvage index as evaluated using cardiac magnetic resonance imaging at 7 days after primary percutaneous coronary intervention (PCI), showed no significant between-group difference (HI: 50.0±24.3%; control: 60.1±20.1%; P=0.43). However, the improvement from day 7 in the HI group was numerically greater than that in the control group in some of the surrogate outcomes at 6-month follow-up, including the LV stroke volume index (HI: 9.2±7.1 mL/m2; control: -1.4±7.2 mL/m2; P=0.03) and the LV ejection fraction (HI: 11.0%±9.3%; control: 1.7%±8.3%; P=0.11). Conclusions: The first clinical study has shown that HI during PCI is feasible and safe and may also promote LV reverse remodeling at 6 months after STEMI. The study was not powered to test efficacy and a further large-scale trial is warranted. (Clinical trials registration: UMIN00006825).
KW - Cardiac magnetic resonance imaging
KW - Hydrogen gas
KW - Left ventricular remodeling
KW - Myocardial infarction
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U2 - 10.1253/circj.CJ-17-0105
DO - 10.1253/circj.CJ-17-0105
M3 - Article
C2 - 28321000
AN - SCOPUS:85021445958
VL - 81
SP - 940
EP - 947
JO - Circulation Journal
JF - Circulation Journal
SN - 1346-9843
IS - 7
ER -