Occurrence of Severe Cardiac Rhythm and Conduction Disturbances in Emergency Department Patients With Non-ST Elevation Acute Coronary Syndrome

Overview

Cardiovascular diseases are the leading cause of death worldwide. Among them, coronary artery disease-especially in its acute form, known as acute coronary syndrome (ACS)-is the most frequent cause of cardiovascular death. There are two main types of ACS: ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation ACS (NSTE-ACS). While the occurrence of serious heart rhythm and conduction disturbances is well established in STEMI, these complications are believed to be much less frequent in NSTE-ACS. However, their actual frequency in this population remains unclear due to limited studies, especially in emergency settings. The main purpose of this study is to estimate the frequency of serious rhythm and conduction disorders in patients presenting with NSTE-ACS in emergency departments. The hypothesis is that these events are rare in this population and may not justify routine continuous cardiac monitoring for all such patients, as currently recommended. Secondary objectives include identifying risk factors for these complications, estimating their frequency during hospitalization, assessing the frequency of minor rhythm and conduction disorders, evaluating care times and patient flow in emergency departments, and assessing patient outcomes up to 30 days-including hospitalizations, length of stay, discharge disposition, all-cause mortality, and the occurrence of five major adverse cardiovascular events (5-point MACE).

Primary outcome measures

• Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department [Time frame: During emergency department stay, assessed up to 24 hours]

Secondary outcome measures (12)

• Incidence of Non-Life-Threatening Arrhythmias or Conduction Disorders in the Emergency Department [Time frame: During emergency department stay, assessed up to 24 hours]
• Number of patients presenting complications prior to a confirmed diagnosis of NSTE-ACS [Time frame: Prior to establishing a confirmed diagnosis of NSTE-ACS in the ED, assessed up to 12 hours]
• Duration of Stay in the Emergency Department [Time frame: From ED admission to hospital admission, discharge, or UHCD discharge; up to 72 hours]
• Number of patients by disposition at emergency department discharge (home vs. hospital admission and type of admitting service [Time frame: At the time of emergency department discharge or transfer, assessed up to 72 hours from ED admission]
• Duration of Hospitalization [Time frame: From hospital admission to hospital discharge, assessed up to 14 days.]
• Number of patients with all-cause mortality or 5-point major adverse cardiovascular events (5P-MACE) at 30 days [Time frame: Day 30 post-ED management]
• Clinical features : weight [Time frame: From admission to discharge from hospital, assessed up to 7 days]
• Clinical features : height [Time frame: From admission to discharge from hospital, assessed up to 7 days]
• Clinical features : heart rate [Time frame: From admission to discharge from hospital, assessed up to 7 days]
• Clinical data : blood and arterial pressure [Time frame: From admission to discharge from hospital, assessed up to 7 days]
• Clinical data : oxygen saturation [Time frame: From admission to discharge from hospital, assessed up to 7 days]
• Clinical data : temperature [Time frame: From admission to discharge from hospital, assessed up to 7 days]

Eligibility criteria

Inclusion criteria

• Adult (≥ 18 years old) patient admitted to the emergency department
• Able to understand the information provided
• Diagnosis of non-ST segment elevation ACS established according to the lastest guidelines from the European Society of Cardiology and the 4th Universal Definition of myocardial infarction
• No objection to participation in the study after receiving appropriate information

Exclusion criteria

• Patients subject to legal protection
• Patient with cognitive impairment
• Myocardial injury and/or symptoms attributable to Takotsubo syndrome, myocarditis, pericarditis, or acute heart failure
• Clinical evidence suggestive of type 2 myocardial infarction, including acute anemia with hemoglobin < 10 g/dL, sepsis, acute hypoxemic respiratory failure

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 10 centers

• Centre Hospitalier de Haguenau — Haguenau
• Centre Hospitalier de Sélestat — Séléstat
• Hôpitaux Universitaires de Strasbourg (NHC) — Strasbourg
• Hôpital Louis Pasteur — Colmar
• Hôpital Emilie Muller — Mulhouse
• Hôpital Maison Blanche — Reims
• CHRU de Nancy — Nancy
• Centre Hospitalier de Pont-à-Mousson — Pont-à-Mousson
• … and 2 more centers

Publications

• Bouisset F, Ruidavets JB, Dallongeville J, Moitry M, Montaye M, Biasch K, Ferrieres J. Comparison of Short- and Long-Term Prognosis between ST-Elevation and Non-ST-Elevation Myocardial Infarction. J Clin Med. 2021 Jan 7;10(2):180. doi: 10.3390/jcm10020180. PMID 33430516
• Pines JM, Pollack CV Jr, Diercks DB, Chang AM, Shofer FS, Hollander JE. The association between emergency department crowding and adverse cardiovascular outcomes in patients with chest pain. Acad Emerg Med. 2009 Jul;16(7):617-25. doi: 10.1111/j.1553-2712.2009.00456.x. Epub 2009 Jun 22. PMID 19549010
• Timmis A, Vardas P, Townsend N, Torbica A, Katus H, De Smedt D, Gale CP, Maggioni AP, Petersen SE, Huculeci R, Kazakiewicz D, de Benito Rubio V, Ignatiuk B, Raisi-Estabragh Z, Pawlak A, Karagiannidis E, Treskes R, Gaita D, Beltrame JF, McConnachie A, Bardinet I, Graham I, Flather M, Elliott P, Mossialos EA, Weidinger F, Achenbach S; Atlas Writing Group, European Society of Cardiology. European Soc PMID 35016208
• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Glob Heart. 2018 Dec;13 PMID 30154043
• Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndrom PMID 37622654
• Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persis PMID 34020768

Identifiers

NCT: NCT07112547 · 9460

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗