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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042398
Receipt No. 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 2020/11/09

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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
Target sample size 30

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
Email 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
Email keiko_kuwahara@mail.toyota.co.jp

Sponsor
Institute Toyota Memorial Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 16 Day
Last follow-up date
2022 Year 03 Month 31 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
2020 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048394

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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