UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cardiac-ASSessment by Independent Observer in Patients with Electrocardiogram-transmIssion for Ambulance-service (CASSIOPEIA) study
Title of the study (Brief title)	CASSIOPEIA study
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 create new flow chart of transmission of electrocardiography for prehospital service, evaluate predictive performance of ST-elevation myocardial infarction (STEMI) and to shorten door to balloon time (DTBT).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sensitivity, specificity, positive predictive value and negative predictive value for STEMI
Key secondary outcomes	door to balloon time (DTBT) achievement ratio of DTBT within 90 min.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	all emergency transferred out-patients to Ninohde hospital all walk-in out patinets as control during study period
Key exclusion criteria	without obtained informed consent
Target sample size	4000

Research contact person
Name of lead principal investigator	Tomonori Itoh
Organization	Iwate Medical University
Division name	Division of Community Medicine, Department of Medical Education / Division of Cardiology, Department of Internal Medicine
Address	19-1, Ucnimaru, Morioka city
TEL	019-651-5111
Email	tomoitoh@iwate-med.ac.jp

Public contact
Name of contact person	Toshiaki Sakai
Organization	Iwate Prefecture Ninohe Hospital
Division name	Department of Cardiology
Address	38-2, Aza Ohkawarage, Horino, Ninohe City, Iwate
TEL	0195-23-2191
Homepage URL
Email	toshi-sakai@outlook.jp

Sponsor
Institute	Department of Cardiology,Iwate Prefecture Ninohe Hospital
Institute
Department

Funding Source
Organization	None
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	2017 Year 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 04 Day
Anticipated trial start date	2014 Year 03 Month 17 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	Published
URL releasing results
Results	Japanese Circulation Society Congress (March, 2017, Kanazawa)
Other related information	Retrospective observational cohort Study All out-patients are divided into the emergency transfer and walk-in patients. Evaluate predictive performance of STEMI using pre-hospital transferred ECG flow chart and efficacy of shortening DTBT by pre-hospital transferred ECG flow chart.

Management information
Registered date	2017 Year 08 Month 20 Day
Last modified on	2017 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032544