UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041010 |
|---|---|
| Receipt number | R000046136 |
| Scientific Title | Feasibility of App-based 22-lead electrocardiogram for the diagnosis of acute coronary syndromes: Single-center, prospective, observational study |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2021/07/07 22:39:54 |
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Basic information
Public title
Comparison of App-based 22-lead electrocardiogram with standard 12-lead electrocardiogram for the diagnosis of acute coronary syndromes
Acronym
Comparative study of App-based 22-lead electrocardiogram with standard 12-lead electrocardiogram
Scientific Title
Feasibility of App-based 22-lead electrocardiogram for the diagnosis of acute coronary syndromes: Single-center, prospective, observational study
Scientific Title:Acronym
Feasibility of App-based 22-lead electrocardiogram for the diagnosis of acute coronary syndromes
Region
| Japan |
Condition
Condition
Acute coronary syndromes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracy of acute coronary syndromes between App-based 22-lead electrocardiogram and standard 12-lead electrocardiogram
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance of App-based 22-lead electrocardiogram and standard 12-lead electrocardiogram with respect to the diagnosis of acute coronary syndromes (ST-elevation myocardial infarction or Non ST-elevation myocardial infarction) and location of myocardial ischemia (only for ST-elevation myocardial infarction)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
key inclusion criteria:
- Patients with acute coronary syndromes who perform standard 12-lead electrocardiogram
- Patients who are > or = 20 years old
- Patients who can provide written informed consent
Key exclusion criteria
key exclusion criteria:
- Patients with complete left bundle branch block
- Patients with pacemaker rhythm
- Patients with abnormal ECG finding due to non-ischemic heart disease (hypertrophic cardiomyopathy, severe valvular heart disease, etc.)
- Patients with cariogenic shock or left main trunk disease
- Patients with severe heart failure and/or intubation
- Patients who can not lie supine due to non-cardiac reasons (back pain, etc.)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kozo |
| Middle name | |
| Last name | Okada |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-Ku, Yokohama Japan
TEL
045-261-5656
kokada2@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kozo |
| Middle name | |
| Last name | Okada |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-Ku, Yokohama, Japan
TEL
045-261-5656
Homepage URL
kokada2@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
This study is scheduled to receive the stuff of App-based 22-lead electrocardiogram from Personal MedSystems.
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
Yokohama City University
Address
3-9, Fukuura, kanazawa-ku, Yokohama, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
| 2020 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center, prospective, observational study
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046136
