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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028753
Receipt No. R000032544
Scientific Title Cardiac-ASSessment by Independent Observer in Patients with Electrocardiogram-transmIssion for Ambulance-service (CASSIOPEIA) study
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/20

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Basic information
Public title Cardiac-ASSessment by Independent Observer in Patients with Electrocardiogram-transmIssion for Ambulance-service (CASSIOPEIA) study
Acronym CASSIOPEIA study
Scientific Title Cardiac-ASSessment by Independent Observer in Patients with Electrocardiogram-transmIssion for Ambulance-service (CASSIOPEIA) study
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomonori Itoh
Organization Iwate Medical University
Division name Division of Community Medicine, Department of Medical Education / Division of Cardiology, Department of Internal Medicine
Zip code
Address 19-1, Ucnimaru, Morioka city
TEL 019-651-5111
Email tomoitoh@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Sakai
Organization Iwate Prefecture Ninohe Hospital
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Japanese Circulation Society Congress
(March, 2017, Kanazawa)
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 Completed
Date of protocol fixation
2014 Year 03 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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