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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

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 - DROP-Asian ACS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042461
Enrollment
4260
Registered
2021-01-01
Start date
2021-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome

Interventions

Usual care 0-1 hr algorithm care

Sponsors

Juntendo University Nerima Hospital Department of Cardiovascular and biology
Lead Sponsor
Roche Diagnostics K.K
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Countries

Japan,Asia(except Japan)

Contacts

Public ContactKenji Inoue

Juntendo University Nerima Hospital Department of Cardiovascular and biology

keinoue@juntendo.ac.jp03-5923-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026