UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043419 |
|---|---|
| Receipt number | R000049574 |
| Scientific Title | Diagnosis of acute myocardial infarction |
| Date of disclosure of the study information | 2021/02/24 |
| Last modified on | 2024/02/26 22:16:18 |
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Basic information
Public title
Diagnosis of acute myocardial infarction
Acronym
Diagnosis of acute myocardial infarction
Scientific Title
Diagnosis of acute myocardial infarction
Scientific Title:Acronym
Diagnosis of acute myocardial infarction
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improve the diagnosis of acute myocardial infarction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between acute myocardial infarction and biomarker
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Suspicion of myocardial infarction
Key exclusion criteria
Trauma, dialysis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
3-18-15, Kuramoto, Tokushima, Japan
TEL
0886339347
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Tokushima University Hospital
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
3-18-15, Kuramoto, Tokushima, Japan
TEL
0886339347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital
Address
2-50-1, Kuramoto, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-u.ac.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
| 2021 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/1422-0067/25/1/573
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/1422-0067/25/1/573
Number of participants that the trial has enrolled
83
Results
In AMI patients who were admitted as early as 3 h or longer after symptom onset, their urinary titin levels were significantly higher than non-AMI patients who are also admitted 3 h or longer after symptom onset (12.76 [IQR 5.87-16.68] pmol/mgCr and 5.13 [IQR 3.93-11.25] pmol/mgCr, p = 0.045, respectively).
Results date posted
| 2024 | Year | 02 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among 83 enrolled patients, 51 patients were diagnosed as AMI
Participant flow
The urinary titin test in ER
Adverse events
None
Outcome measures
Urinary titin
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the factors related to the diagnosis of acute myocardial infarction.
Management information
Registered date
| 2021 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049574
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
