Unique ID issued by UMIN | UMIN000042398 |
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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 |
Clinical study about the suppression of ventricular remodeling and the improvement of heart failure indices by active oxygen administration for acute myocardial infarction patients
AMI-AOT study
Clinical study about the suppression of ventricular remodeling and the improvement of heart failure indices by active oxygen administration for acute myocardial infarction patients
AMI-AOT (active oxygen therapy ) study
Japan |
ST-segment elevation myocardial infarction
Cardiology |
Others
NO
To evaluate the therapeutic effects of oxygen administration in the acute phase of myocardial infarction
Safety,Efficacy
Rate of change of the BNP value
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Other |
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.
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.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
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
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
100
1st name | Koichi |
Middle name | |
Last name | Kobayashi |
Toyota Memorial Hospital
Department of Cardiology
4718513
1-1,Hewiwa-cho,Toyota,Aichi
0565-28-0100
koichi_kobayashi_ab@mail.toyota.co.jp
1st name | Keiko |
Middle name | |
Last name | Kuwahara |
Toyota Memorial Hospital
Clinical Research Department
4718513
1-1,Hewiwa-cho,Toyota,Aichi
0565-28-0100
keiko_kuwahara@mail.toyota.co.jp
Toyota Memorial Hospital
None
Self funding
Toyota Memorial Hospital Clinical Research Review Committee
1-1,Hewiwa-cho,Toyota,Aichi
0565-28-0100
ya-kenkyu@mail.toyota.co.jp
NO
2020 | Year | 11 | Month | 09 | Day |
Unpublished
Open public recruiting
2020 | Year | 10 | Month | 15 | Day |
2020 | Year | 10 | Month | 15 | Day |
2020 | Year | 11 | Month | 16 | Day |
2026 | Year | 09 | Month | 30 | Day |
2020 | Year | 11 | Month | 09 | Day |
2024 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048394
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