UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The safety and efficacy of inhalation of H2 gas during PCI in patients with acute myocardial infarction
Title of the study (Brief title)	Inhalation of H2 gas in patients with acute myocardial infarction
Region	Japan

Condition
Condition	Acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is designed to investigate whether inhalation of hydrogen gas during primary percutaneous coronary intervention can reduce infarct size and prevent left ventricular remodeling in patients with acute myocardial infarction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the extent of myocardial lethal ischemia-reperfusion injury by cardiovascular magnetic resonance imaging 7 days after acute myocardial infarction
Key secondary outcomes	Angiographic assessment of reperfusion by TIMI flow grade and myocardial blush grade Assessment of reperfusion by ST resolution Assessment of infarct size by area under the curve-creatine phosphokinase (CPK) Assessment of left ventricular failure by Killip classification Evaluation of wall motion abnormalities and left ventricular ejection fraction by cine MRI 7 days after acute myocardial infarction Evaluation of left ventricular ejection fraction and infarct size by cardiac MRI imaging

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	H2 gas inhalation group: H2-mixed gas (H2 1.3%, O2 26%, N2 74%) Patients who suspect that they are having an acute myocardial infarction at an emergency room start to inhale gas and continue to inhale gas during PCI procedure.
Interventions/Control_2	Control group: control gas (O2 26%, N2 74%) Patients who suspect that they are having an acute myocardial infarction at an emergency room start to inhale gas and continue to inhale gas during PCI.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	ST-segment elevation myocardial infarction Within 24 hours following the onset of chest pain
Key exclusion criteria	Shock (BP<90mmHg) Severe hypoxia (SpO2<90%) Sustained VT or VF Post-cardiopulmonary resuscitation Patients with absolute contraindications to MRI scans
Target sample size	40

Research contact person
Name of lead principal investigator	Motoaki Sano
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjyuku-ku Tokyo, 160-8582, Japan
TEL	81-3-5363-3874
Email

Public contact
Name of contact person	Motoaki Sano
Organization	Keio University School of Medicine
Division name	Department of Cardiology
Address	35 Shinanomachi Shinjyuku-Ku Tokyo, 160-8582, Japan
TEL	03-5363-3874
Homepage URL
Email	msano@a8.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	TAIYO NIPPON SANSO
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 08 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 10 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/circj/81/7/81_CJ-17-0105/_article
Results
Other related information

Management information
Registered date	2011 Year 12 Month 04 Day
Last modified on	2017 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008076