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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014390
Receipt No. R000016749
Scientific Title The efficacy of hydrogen gas inhalation during Perctaneous Coronary Intervention in patients with ST elevation acute myocardial infarction
Date of disclosure of the study information 2014/07/01
Last modified on 2018/07/02

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Basic information
Public title The efficacy of hydrogen gas inhalation during Perctaneous Coronary Intervention in patients with ST elevation acute myocardial infarction
Acronym The efficacy of hydrogen gas Inhalation in patients with ST elevation acute myocardial infarction
Scientific Title The efficacy of hydrogen gas inhalation during Perctaneous Coronary Intervention in patients with ST elevation acute myocardial infarction
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisao Hara
Organization National Center for Global Health and Medicine
Division name Department of Cardiology
Zip code
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
1st name
Middle name
Last name Hisao Hara
Organization National Center for Global Health and Medicine
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 04 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000016749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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