The effects of hydrogen gas inhalation on adverse left ventricular remodeling after percutaneous coronary intervention for ST-elevated myocardial infarction: First pilot study in humans

Yoshinori Katsumata, Fumiya Sano, Takayuki Abe, Tomoyoshi Tamura, Taishi Fujisawa, Yasuyuki Shiraishi, Shun Kosaka, Ikuko Ueda, Koichiro Honma, Masaru Suzuki, Shigeo Okuda, Yuichiro Maekawa, Eiji Kobayashi, Shingo Hori, Junichi Sasaki, Keiichi Fukuda, Motoaki Sano

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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).

Original languageEnglish
Pages (from-to)940-947
Number of pages8
JournalCirculation Journal
Volume81
Issue number7
DOIs
Publication statusPublished - 2017

Fingerprint

Ventricular Remodeling
Percutaneous Coronary Intervention
Inhalation
Hydrogen
Gases
Stroke Volume
Oxygen
Control Groups
ST Elevation Myocardial Infarction
Myocardial Infarction
Magnetic Resonance Imaging
Clinical Trials

Keywords

  • Cardiac magnetic resonance imaging
  • Hydrogen gas
  • Left ventricular remodeling
  • Myocardial infarction

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

The effects of hydrogen gas inhalation on adverse left ventricular remodeling after percutaneous coronary intervention for ST-elevated myocardial infarction : First pilot study in humans. / Katsumata, Yoshinori; Sano, Fumiya; Abe, Takayuki; Tamura, Tomoyoshi; Fujisawa, Taishi; Shiraishi, Yasuyuki; Kosaka, Shun; Ueda, Ikuko; Honma, Koichiro; Suzuki, Masaru; Okuda, Shigeo; Maekawa, Yuichiro; Kobayashi, Eiji; Hori, Shingo; Sasaki, Junichi; Fukuda, Keiichi; Sano, Motoaki.

In: Circulation Journal, Vol. 81, No. 7, 2017, p. 940-947.

Research output: Contribution to journalArticle

Katsumata, Yoshinori ; Sano, Fumiya ; Abe, Takayuki ; Tamura, Tomoyoshi ; Fujisawa, Taishi ; Shiraishi, Yasuyuki ; Kosaka, Shun ; Ueda, Ikuko ; Honma, Koichiro ; Suzuki, Masaru ; Okuda, Shigeo ; Maekawa, Yuichiro ; Kobayashi, Eiji ; Hori, Shingo ; Sasaki, Junichi ; Fukuda, Keiichi ; Sano, Motoaki. / The effects of hydrogen gas inhalation on adverse left ventricular remodeling after percutaneous coronary intervention for ST-elevated myocardial infarction : First pilot study in humans. In: Circulation Journal. 2017 ; Vol. 81, No. 7. pp. 940-947.
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abstract = "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).",
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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 - Kosaka, Shun

AU - Ueda, Ikuko

AU - Honma, 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

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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