UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of hydrogen gas inhalation during Perctaneous Coronary Intervention in patients with ST elevation acute myocardial infarction
Title of the study (Brief title)	The efficacy of hydrogen gas Inhalation in patients with ST elevation 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 hydrogen gas inhalation during primary percutaneous coronary intervention can reduce infarct size in patients with ST elevation 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 ischemia-reperfusion injury by cardiovascular magnetic resonance imaging 30 days after acute myocardial infarction
Key secondary outcomes	Angiographic assessment of reperfision by TIMI flow grade and myocardial blush grade. Assessment of reperfusion by ST resolution comparison of prePCI and post PCI. Assessment of infarct size by creatine phosphokinase (CPK). Assessment of left ventricular failure by Killip classification. Evaluation of left ventricular ejection fraction and infarct size by cardiac MRI imaging in chronic phase. Assesment of major advance cardiac event.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	Patients who diagnose that they are having an acute myocardial infarction at a cardiovascular angiogram 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 diagnose that they are having an acute myocardial infarction at a cardiovascular angiogram 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	90 years-old >
Gender	Male and Female
Key inclusion criteria	ST-segment elevation myocardial infarction within 12hours following the onset of chest pain
Key exclusion criteria	Shock (BP<90mmHg) Patient of Congestive Heart Failure or Severe hypoxia (SpO2<94% using nasal 4l O2 inhale) Sustained VT or VF Post-cardiopulmonary resuscitation Patients with absolute contraindications to MRI scans The patient who is not provided of the written agreement. The patient who judged a trial entry doctor to be inappropriate as an object of the final examination.
Target sample size	50

Research contact person
Name of lead principal investigator	Hisao Hara
Organization	National Center for Global Health and Medicine
Division name	Department of Cardiology
Address	1-21-1Toyama Shinjyuku-ku Tokyo,162-8655, Japan
TEL	03-3202-7181
Email	hhara@hosp.ncgm.go.jp

Public contact
Name of contact person	Hisao Hara
Organization	National Center for Global Health and Medicine
Division name	Department of Cardiology
Address	1-21-1 Toyama Shinjyuku-ku Tokyo, 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	hhara@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and 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	2014 Year 07 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 04 Month 26 Day
Anticipated trial start date	2013 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 26 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016749