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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030668
Receipt No. R000035013
Scientific Title Diagnostics and Reduction of Asian Patients with Acute coronary syndrome Cost Analysis Base on The 0-hour/1-hour algorithm using High-sensitivity cardiac Troponin.
Date of disclosure of the study information 2018/01/03
Last modified on 2019/07/08

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Basic information
Public title Diagnostics and Reduction of Asian Patients with Acute coronary syndrome Cost Analysis Base on The 0-hour/1-hour algorithm using High-sensitivity cardiac Troponin.
Acronym DROP-ACS database
Scientific Title Diagnostics and Reduction of Asian Patients with Acute coronary syndrome Cost Analysis Base on The 0-hour/1-hour algorithm using High-sensitivity cardiac Troponin.
Scientific Title:Acronym DROP-ACS database
Region
Japan Asia(except Japan)

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

Objectives
Narrative objectives1 1) We aim to prospectively validate the diagnostic accuracy of the recently developed 0-h/1-h algorithm, using high-sensitivity cardiac troponin for the early rule-out and rule-in of acute myocardial infarction (AMI) with or without renal insufficiency in Asian countries.
2) We aim to assess the clinical effectiveness and cost-effectiveness of hs-cTn assays for the early rule-out of AMI in adults with acute chest pain.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Major advance cardiac event including death, cardiac death, acute myocardial infarction, unstable angina, re-vascularization, cerebral vascular accident) at 30 days and 1 year.
Key secondary outcomes cost effectiveness

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
30 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (such as acute chest pain and angina pectoris) with an onset or maximum of discomfort or pain within the previous 12 hours were identified by study personnel and recruited after written informed consent had been obtained.
Key exclusion criteria 1) ST elevation myocardial infarction
2) History of trauma, sepsis, or cardiac arrest on the registration.
3) Malignant disease. The prognosis is less than 1 year.
4) History of admission due to cardiac disease including myocardial infarction, congestive heart failure, or coronary revascularization in three months prior to the registration.
5) Hemodialysis state.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Kenji
Organization Juntendo University Nerima Hospital
Division name Cardiology
Zip code 1770033
Address 3-1-10, Nerimaku Takanedai, Tokyo, Japan
TEL 81-3-5923-3111
Email inouelsbm@gmail.com

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kenji
Organization Juntendo University Nerima Hospital
Division name Cardiology
Zip code 1770033
Address 3-1-10, Nerimaku Takanedai, Tokyo, Japan
TEL 81-3-5923-3111
Homepage URL
Email inouelsbm@gmail.com

Sponsor
Institute Juntendo University Nerima 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 Juntendo University Nerima Hospital
Address 3-1-10, Nerimaku Takanodai, Tokyo
Tel 0359233111
Email inouelsbm@gmail.com

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 01 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 06 Month 15 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 01 Month 03 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035013

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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