UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006825 |
|---|---|
| Receipt number | R000008076 |
| Scientific Title | The safety and efficacy of inhalation of H2 gas during PCI in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2011/12/04 |
| Last modified on | 2017/12/11 21:46:08 |
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Basic information
Public title
The safety and efficacy of inhalation of H2 gas during PCI in patients with acute myocardial infarction
Acronym
Inhalation of H2 gas in patients with acute myocardial infarction
Scientific Title
The safety and efficacy of inhalation of H2 gas during PCI in patients with acute myocardial infarction
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Motoaki Sano |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjyuku-ku Tokyo, 160-8582, Japan
TEL
81-3-5363-3874
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoaki Sano |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi Shinjyuku-Ku Tokyo, 160-8582, Japan
TEL
03-5363-3874
Homepage URL
msano@a8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/81/7/81_CJ-17-0105/_article
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 08 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008076
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
