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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042461
Receipt No. R000048466
Scientific Title An International, Stepped-Wedge, Cluster-Randomized Trial Investigating the 0/1-hour Algorithm in Suspected Acute Coronary Syndrome in Asia:The rational of the DROP-Asian ACS study
Date of disclosure of the study information 2021/01/01
Last modified on 2021/07/07

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Basic information
Public title An International, Stepped-Wedge, Cluster-Randomized Trial Investigating the 0/1-hour Algorithm in Suspected Acute Coronary Syndrome in Asia:The rational of the DROP-Asian ACS study
Acronym DROP-Asian ACS
Scientific Title An International, Stepped-Wedge, Cluster-Randomized Trial Investigating the 0/1-hour Algorithm in Suspected Acute Coronary Syndrome in Asia:The rational of the DROP-Asian ACS study
Scientific Title:Acronym DROP-Asian ACS
Region
Japan Asia(except Japan)

Condition
Condition acute coronary syndrome
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Aim of this study is to quantify the impact of the use of the 0-1-hr/algorithm care on patient outcome and on costs in patients with chest pain presenting at the emergency room, as compared to usual care.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes MACE (Major Adverse Cardiac Events) including cardiac death and AMI within 30 days after presentation.
Key secondary outcomes 1) Costs for health care resource and the duration of stay in the emergency department.
2) All cause death within 30 days after presentation.
3) Unexpected hospitalization due to cardiac reason including congestive heart failure, urgent coronary angiography, percutaneous coronary intervention/ or coronary artery bypass graft within 30 days after presentation.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Usual care
Interventions/Control_2 0-1 hr algorithm care
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
18 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients presenting to the emergency department.
Patients qualified for enrollment with initial presentation of clinically suspected ACS, based on a broad spectrum of symptoms including atypical symptoms and dyspnoea.
Onset of symptoms within the last 24 hours prior to presentation
Written informed consent
Key exclusion criteria Children (age <30 years) are excluded from study participation.
ST elevation myocardial infarction
On chronic hemodialysis
A clear alternative case for the symptoms othe than ACS
Symptomatic patients with atrioventricular nodal re-entrant tachycardia demonstrate ST-segment depressions and relevant troponin kinetics. Because it is impossible to make a different diagnosis with type 1 MI, type 2 MI, MI with non-obstructive coronary arteries, or acute myocardial injury, we decided not to include these patients.
Acute heart failure due to already known non-coronary heart disease without suspected ACS.
Congestive heart failure with hypoxemia
Infection
Cariogenic shock
Dementia (Mini Mental State Examination; MMSE less than 20).
Confirmed primary pulmonary disease without suspected ACS.
Traumatic chest pain with preceded thorax injury without suspected ACS.
Inability or unwillingness to provide informed consent
Target sample size 3322

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Inoue
Organization Juntendo University Nerima Hospital
Division name Department of Cardiovascular and biology
Zip code 177-0033
Address 3-1-10, Nerimaku Takanodai, Tokyo, Japan
TEL 03-5923-3111
Email keinoue@juntendo.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Inoue
Organization Juntendo University Nerima Hospital
Division name Department of Cardiovascular and biology
Zip code 177-0033
Address 3-1-10, Nerimaku Takanodai, Tokyo, Japan
TEL 03-5923-3111
Homepage URL
Email keinoue@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Department of Cardiovascular and biology
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Roche Diagnostics K.K
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Nerima Hospital
Address 3-1-10, Nerimaku Takanodai, Tokyo, Japan
Tel 03-5923-3111
Email keinoue@juntendo.ac.jp

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 順天堂大学医学部附属練馬病院(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 01 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 16 Day
Last modified on
2021 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048466

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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