UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031197 |
|---|---|
| Receipt number | R000035616 |
| Scientific Title | Developement of prehospital diagnostic scale for stroke and acute coronary syndrome |
| Date of disclosure of the study information | 2018/02/14 |
| Last modified on | 2019/02/11 23:00:16 |
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Basic information
Public title
Developement of prehospital diagnostic scale for stroke and acute coronary syndrome
Acronym
Developement of prehospital diagnostic scale for stroke and acute coronary syndrome
Scientific Title
Developement of prehospital diagnostic scale for stroke and acute coronary syndrome
Scientific Title:Acronym
Developement of prehospital diagnostic scale for stroke and acute coronary syndrome
Region
| Japan |
Condition
Condition
Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, myocardial infarction, angina, coronary artery stenosis
Classification by specialty
| Cardiology | Neurology | Neurosurgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to develop a scale to improve the accuracy of a prehospital diagnosis of the emergency patients who develop brain or cardiovascular event (i.e. stroke or acute coronary syndrome).
Basic objectives2
Others
Basic objectives -Others
To contribute to appropriate hospital choice and reduction of the staying time
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of stroke or acute coronary disease
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who call the emergency service in Chiba city
(2)Those who are suspected by ambulance crew to be stroke or acute coronary disease
(3)20years or older
Key exclusion criteria
(1)When the proposal of not participating in this study is offered from a patient or a patient family.
(2)Patient whom doctor evaluate not to be an appropriate subject.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Oda |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba city, Chiba 260-8677, JAPAN
TEL
043-226-2341
odas@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taka-aki Nakada |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuo, Chiba city, Chiba 260-8677, JAPAN
TEL
043-226-2341
Homepage URL
taka.nakada@nifty.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035616
