UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030668 |
|---|---|
| Receipt number | 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 | 2024/01/08 10:02:26 |
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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
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
inouelsbm@gmail.com
Sponsor or person
Institute
Juntendo University Nerima 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
Juntendo University Nerima Hospital
Address
3-1-10, Nerimaku Takanodai, Tokyo
Tel
0359233111
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
10.1253/circj.CJ-23-0064
Publication of results
Partially published
Result
URL related to results and publications
10.1253/circj.CJ-23-0064
Number of participants that the trial has enrolled
899
Results
If the diagnostic accuracy of the 0/1-h algorithm was implemented in Hospital B, it is expected that the number of urgent (<24-h) coronary angiograms would decrease by 50%. Incorporating this assumption, implementing the 0/1-h algorithm could potentially reduce medical costs by JPY4,033,874 (95% CI JPY3,440,346-4,627,402) in Hospital B (JPY9,447 per patient; 95% CI JPY 8,057-10,837 per patient).
Results date posted
| 2023 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 03 | Day |
Baseline Characteristics
A cost-effectiveness analysis was conducted with 472 patients with care provided following the 0/1-h algorithm (Hospital A) and 427 patients following point-of-care testing (Hospital B).
Participant flow
Patients of more than18 years of age who presented to the ED of participating hospitals with symptoms suggestive of NSTE-ACS (e.g., chest pain, epigastric pain, radiating pain to the neck or shoulder, shortness of breath) are eligible for enrollment in the DROP-Asian ACS study, if the onset of symptoms occurred within the last 12 h.Patients were excluded from the present study if they presented with ST elevation myocardial infarction, cardiogenic shock, on chronic hemodialysis, or chest pain following chest trauma, or if they were unwilling or unable to pro- vide their informed consent. All participating patients or their legally authorized representatives will provide writ- ten informed consent.
Adverse events
None
Outcome measures
The primary aim of the present study is to determine the relative safety of the 0/1-h algorithm compared with the current standard of care for patients presenting with sus- pected NSTE-ACS to the ED. Primary outcome measure is the incidence of major adverse cardiac events (MACE), defined as the composite of cardiovascular death, new acute myocardial infarction (AMI) (type 1 or 2), unstable angina, or unexpected revascularization within 30 days (defined as any unplanned hospitalization with cardiac revascularization performed within the first 12 h after hospital admission in the context of ACS). Of note, AMI diagnosed within 12 h of index presentation among par- ticipants continuously in-hospital will be considered as the index presenting AMI and not included as an end- point event. An AMI documented to have commenced outside this time (recurrent/new AMI type 1 or 2) in hospitalized patients or within 12 h of index presentation among participants already discharged from the hospital (missed AMI type 1 or 2) will be considered an endpoint event.
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
| 2024 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 01 | Month | 03 | Day |
Last modified on
| 2024 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035013
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