Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Dec 7;23(1):986.
doi: 10.1186/s13063-022-06907-4.

An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

Kenji Inoue  1 , Jack Tan Wei Chieh  2 , Lim Chiw Yeh  2 , Shuo-Ju Chiang  3 , Arintaya Phrommintikul  4 , Pannipa Suwanasom  4 , Sazzli Kasim  5 , Bakhtiar Ahmad  5 , Alzamani Mohammad Idrose  6 , Farina Mohd Salleh  7 , Shunsuke Oyamada  8 , Yohei Hirano  9 , Shohei Ouchi  10 , Moriyuki Terakura  11 , Naoyuki Yokoyama  12 , Ken Kozuma  12 , Mamoru Nanasato  13 , Ryosuke Higuchi  13 , Kazuhiko Yumoto  14 , Tomoyuki Fukuzawa  14 , Issei Shimada  15 , Evangelos Giannitsis  16 , Raphael Twerenbold  17 , Tohru Minamino  18
Affiliations
Randomized Controlled Trial

An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

Kenji Inoue et al. Trials. .

Erratum in

Abstract

Background: More than half of the world's population lives in Asia. With current life expectancies in Asian countries, the burden of cardiovascular disease is increasing exponentially. Overcrowding in the emergency departments (ED) has become a public health problem. Since 2015, the European Society of Cardiology recommends the use of a 0/1-h algorithm based on high-sensitivity cardiac troponin (hs-cTn) for rapid triage of patients with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). However, these algorithms are currently not recommended by Asian guidelines due to the lack of suitable data.

Methods: The DROP-Asian ACS is a prospective, stepped wedge, cluster-randomized trial enrolling 4260 participants presenting with chest pain to the ED of 12 acute care hospitals in five Asian countries (UMIN; 000042461). Consecutive patients presenting with suspected acute coronary syndrome between July 2022 and Apr 2024 were included. Initially, all clusters will apply "usual care" according to local standard operating procedures including hs-cTnT but not the 0/1-h algorithm. The primary outcome is the incidence of major adverse cardiac events (MACE), the composite of all-cause death, myocardial infarction, unstable angina, or unplanned revascularization within 30 days. The difference in MACE (with one-sided 95% CI) was estimated to evaluate non-inferiority. The non-inferiority margin was prespecified at 1.5%. Secondary efficacy outcomes include costs for healthcare resources and duration of stay in ED.

Conclusions: This study provides important evidence concerning the safety and efficacy of the 0/1-h algorithm in Asian countries and may help to reduce congestion of the ED as well as medical costs.

Keywords: 0-h/1-h algorithm; High-sensitivity troponin T; Non-ST elevation of acute coronary syndrome; Overcrowding emergency department.

PubMed Disclaimer

Conflict of interest statement

Dr. Inoue has received research grant from Grant-in-Aid for Scientific Research C, No. 18K09954), Roche Diagnostics, SB Bioscience Co., Ltd., Fujirebio Inc., Bayel Sysmex and Kanto Chemical Co. Inc.

Dr. Twerenbold reports research support from the Swiss National Science Foundation (Grant No P300PB_167803), the Swiss Heart Foundation, the Swiss Society of Cardiology, the Cardiovascular Research Foundation Basel, the University of Basel, and the University Hospital Basel and speaker honoraria/consulting honoraria from Abbott, Amgen, Astra Zeneca, Roche, Siemens, Singulex, and Thermo Scientific BRAHMS.

Dr. Giannitsis declares honoraria for lectures from Daiichi Sankyo, Astra Zeneca, Roche Diagnostics, Boehringer Ingelheim, Bayer Vital, and BRAHMS GmbH. He receives research funding from Daiichi Sankyo and Roche Diagnostics. He consults Roche Diagnostics, Astra Zeneca, Bayer Vital, Indorsia, Radiometer, BRAHMS GmbH, Hoffmann-La Roche, and Boehringer Ingelheim.

Dr. JWCT has received honoraria from AstraZeneca, Bayer, Amgen, Medtronic, Abbott Vascular, Biosensors, Alvimedica, Boehringer Ingelheim, and Pfizer; research and educational grants from Medtronic, Biosensors, Biotronik, Philips, Amgen, AZ, Roche, Ostuka, Terumo, and Abbott Vascular; and consulting fees from Elixir, CSL Behring.

Dr. Minamino has received research grant from Roche Diagnostics.

Figures

Fig. 1
Fig. 1
Participants. Six hospitals from Japan, and 3 hospitals from Malaysia join. Juntendo Urayasu Hospital and Shimada general hospital is in one cluster due to highly comparable geographical conditions (Chiba, Japan) and the expected relatively low number of enrollments (They can enroll patients during Monday to Friday, 9 a.m. to 4.p.m.)
Fig. 2
Fig. 2
Study design. This study consists of 11 clusters with 12 hospitals. At study start, all clusters will apply “usual care” (control condition) to all patients, i.e., risk assessment and subsequent management includes hs-cTnT but not the application of the 0/1-h algorithm. One randomly allocated cluster will sequentially start to follow the 0/1-h algorithm after a transition period of 1.5 months in all chest pain patients (intervention condition; 0/1 care)
See this image and copyright information in PMC

References

    1. Sprivulis PC, Da Silva JA, Jacobs IG, Frazer AR, Jelinek GA. The association between hospital overcrowding and mortality among patients admitted via Western Australian emergency departments. Med J Aust. 2006;184(5):208–212. doi: 10.5694/j.1326-5377.2006.tb00203.x. - DOI - PubMed
    1. Hoot NR, Aronsky D. Systematic review of emergency department crowding: causes, effects, and solutions. Ann Emerg Med. 2008;52(2):126–136. doi: 10.1016/j.annemergmed.2008.03.014. - DOI - PMC - PubMed
    1. Schull MJ, Vermeulen M, Slaughter G, Morrison L, Daly P. Emergency department crowding and thrombolysis delays in acute myocardial infarction. Ann Emerg Med. 2004;44(6):577–585. doi: 10.1016/j.annemergmed.2004.05.004. - DOI - PubMed
    1. Lee TH, Goldman L. Evaluation of the patient with acute chest pain. N Engl J Med. 2000;342(16):1187–1195. doi: 10.1056/NEJM200004203421607. - DOI - PubMed
    1. Bandstein N, Ljung R, Holzmann MJ. Risk of revisits to the emergency department in admitted versus discharged patients with chest pain but without myocardial infarction in relation to high-sensitivity cardiac troponin T levels. Int J Cardiol. 2016;203:341–346. doi: 10.1016/j.ijcard.2015.10.170. - DOI - PubMed

Publication types

LinkOut - more resources