UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042461 |
|---|---|
| Receipt number | 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 | 2023/11/19 16:48:12 |
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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
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).
Key secondary outcomes
1) The proportion of patients managed as outpatients in order to quantify the efficacy of the investigated approaches in both arms.
2) The time from ED presentation to discharge in outpatients. The ED dwell time is derived from a common electronic patient record system used across all participating sites and is calculated as the time of the medical examination between the start time (sign-in time: defined as first medical contact with a MD or the triage nurse) and the end time (sign-off time: defined as the time when the attending physician has finished all medical procedures in the ED, including charting, with the patient to ready to leave the examination room either to be discharged or transferred to a different unit/ward within the hospital).
3) All-cause mortality (cardiovascular death and non-cardiovascular death) and new myocardial infarction (type 1 or 2) within 30 days after the index presentation.
4) Incidence of any cardiac revascularization within 30 days after the index presentation
5) Incidence of ED representation or hospitalization for unstable angina within 30 days after the index presentation.
6) Costs for healthcare resource use within 30 days following the index ED presentation are calculated based on the guidelines of each countries and cost tables for hospitals. Different costs are used for academic and general hospitals. For each patient, the costs are calculated based on the observed number and type of healthcare resources used.
7) Incidence of cardiac examinations (e.g., stress testing or coronary angiography) within 30 days after the index presentation. Adherence to the intervention condition (the 0/1-h algorithm) was evaluated.
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.
Written informed consent
Key exclusion criteria
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
4260
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
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
keinoue@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Nerima Hospital
Department of Cardiovascular and biology
Institute
Department
Personal name
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
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
3728
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048466
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