UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Developement of prehospital diagnostic scale for stroke and acute coronary syndrome
Title of the study (Brief title)	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	Shigeto Oda
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Address	1-8-1 Inohana, Chuo, Chiba city, Chiba 260-8677, JAPAN
TEL	043-226-2341
Email	odas@faculty.chiba-u.jp

Public contact
Name of contact person	Taka-aki Nakada
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Address	1-8-1 Inohana, Chuo, Chiba city, Chiba 260-8677, JAPAN
TEL	043-226-2341
Homepage URL
Email	taka.nakada@nifty.com

Sponsor
Institute	Chiba University Graduate School of Medicine, Department of Emergency and Critical Care Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035616