UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013587 |
|---|---|
| Receipt number | R000014777 |
| Scientific Title | Incremental Value and Utility of the Bipolar leads- CMf, CM2, CM5- for detecting STEMI at Pre-Hospital setting: multicenter observational study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2018/04/03 09:13:11 |
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Basic information
Public title
Incremental Value and Utility of the Bipolar leads- CMf, CM2, CM5- for detecting STEMI at Pre-Hospital setting: multicenter observational study
Acronym
Incremental Value and Utility of the Bipolar leads- CMf, CM2, CM5- for detecting STEMI at Pre-Hospital setting
Scientific Title
Incremental Value and Utility of the Bipolar leads- CMf, CM2, CM5- for detecting STEMI at Pre-Hospital setting: multicenter observational study
Scientific Title:Acronym
Incremental Value and Utility of the Bipolar leads- CMf, CM2, CM5- for detecting STEMI at Pre-Hospital setting
Region
| Japan |
Condition
Condition
ST elevation myocardial infarction
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether adding the three CM leads to simple history taking improve the diagnostic accuracy for detecting STEMI at pre-hospital setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Net Reclassification improvement (NRI) of adding CM2 and CM5 leads to history taking and CMf leads, which is a substitute for II lead, for detecting STEMI
Key secondary outcomes
Diagnostic accuracy of three CM leads at prehospital setting for detecting STEMI- sensitivity, specificity, positive predictive value, negative predictive value-
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. adults who is 30 years or older
2. patients who call emergency medical service in Sakai City and whose main complaint is symptoms related with cardiac ischemia ; pain of chest, epigastric, shoulder or jaw, or sudden onset short of breath
3. duration of symptom is 15 minutes or longer
Key exclusion criteria
1. 24 hours pass since the onset of symptom
2. the symptom is due to trauma
3. patients with cardiac arrest
4. patients with complete left bundle brock at 12 leads ECG
Target sample size
630
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junji Kumasawa |
Organization
Kyoto University School of Public Health
Division name
Epidemiology and Healthcare research
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
jkumakumakuma@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Kumasawa |
Organization
Kyoto University School of Public Health
Division name
Epidemiology and Healthcare research
Zip code
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
TEL
075-753-4646
Homepage URL
jkumakumakuma@hotmail.com
Sponsor or person
Institute
Kyoto University School of Public Health
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
Sakai City Hospital, Asakayama Hospital, Osaka Rosai Hospital, Bellland General Hospital, Mimihara General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Sakai City Hospital (Osaka)
Asakayama Hospital (Osaka)
Osaka Rosai Hospital (Osaka)
Bellland General Hospital (Osaka)
Mimihara General Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective, Cross sectional study.
Consecutive patients with eligibility will be included in this study.
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014777
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
