UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014390 |
|---|---|
| Receipt number | 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 12:29:19 |
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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
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
hhara@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016749
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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