UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028753
Receipt number 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 23:26:53

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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 or person

Institute

Department of Cardiology,Iwate Prefecture Ninohe Hospital

Institute

Department

Personal name



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

Value
https://center6.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