UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042398 |
|---|---|
| Receipt number | R000048394 |
| Scientific Title | Clinical study about the suppression of ventricular remodeling and the improvement of heart failure indices by active oxygen administration for acute myocardial infarction patients |
| Date of disclosure of the study information | 2020/11/09 |
| Last modified on | 2024/01/11 16:33:20 |
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Basic information
Public title
Clinical study about the suppression of ventricular remodeling and the improvement of heart failure indices by active oxygen administration for acute myocardial infarction patients
Acronym
AMI-AOT study
Scientific Title
Clinical study about the suppression of ventricular remodeling and the improvement of heart failure indices by active oxygen administration for acute myocardial infarction patients
Scientific Title:Acronym
AMI-AOT (active oxygen therapy ) study
Region
| Japan |
Condition
Condition
ST-segment elevation myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic effects of oxygen administration in the acute phase of myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change of the BNP value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Study-treatment
Active oxygen administration of 5 L/min with a nasal cannula for 96 hours after the onset.
The change to a mask or the reduction to 4L/min of oxygen are permitted for the stable administration and patient comfort.
Interventions/Control_2
Standard treatment(control)
Minimum administration of oxygen to keep 90 % of oxygen saturation (SpO2).
Oxygen of 1 to 5 L/min is applied to keep 90 to 92 % of SpO2. Oxygen flow is adjusted by 1 L/min every 3 hours.
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
1) Subjects with acute myocardial infarction, aged 20 to 80 years old, at the time of informed consent
2) Subjects with sustained ST elevation in electrocardiogram
3) Subjects within four hours after the onset of symptom
4) Subjects with the elevation of troponin more than the double of the normal limit at the time of admission or after the catheter intervention
Key exclusion criteria
1)Subjects with oxygen condition less than 90% of SpO2 in room air
2)Subjects with pulmonary congestion in chest X-ray
3)Subjects who need an urgent coronary artery bypass graft surgery
4)Subjects with systolic blood pressure less than 100 mmHg
5)Subjects with long-term domiciliary oxygen therapy or CPAP therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Kobayashi |
Organization
Toyota Memorial Hospital
Division name
Department of Cardiology
Zip code
4718513
Address
1-1,Hewiwa-cho,Toyota,Aichi
TEL
0565-28-0100
koichi_kobayashi_ab@mail.toyota.co.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kuwahara |
Organization
Toyota Memorial Hospital
Division name
Clinical Research Department
Zip code
4718513
Address
1-1,Hewiwa-cho,Toyota,Aichi
TEL
0565-28-0100
Homepage URL
keiko_kuwahara@mail.toyota.co.jp
Sponsor or person
Institute
Toyota Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyota Memorial Hospital Clinical Research Review Committee
Address
1-1,Hewiwa-cho,Toyota,Aichi
Tel
0565-28-0100
ya-kenkyu@mail.toyota.co.jp
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
| 2020 | Year | 11 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048394
| 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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