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

NCT07112547 | Not Yet Recruiting

• 1 other identifier: 9460
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Acute Coronary Syndrome Without ST Elevation on Electrocardiogram; Acute Coronary Syndromes (ACS); Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease

Keywords

Non-ST Segment Elevation Acute Coronary Syndrome; Cardiac Arrhythmias; Heart Conduction System Disease; Hospital Emergency Service; Electrocardiographic monitoring; Cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department

  Occurrence of at least one serious rhythm or conduction disturbance during emergency department management, including: sustained ventricular tachycardia (VT), ventricular fibrillation (VF), torsades de pointes, high-degree conduction disorders (Mobitz type II AV block, third-degree AV block, trifascicular block), pulseless electrical activity (PEA), and asystole.

  During emergency department stay, assessed up to 24 hours

Secondary Outcomes (24)

• Incidence of Non-Life-Threatening Arrhythmias or Conduction Disorders in the Emergency Department

  During emergency department stay, assessed up to 24 hours

• Number of patients presenting complications prior to a confirmed diagnosis of NSTE-ACS

  Prior to establishing a confirmed diagnosis of NSTE-ACS in the ED, assessed up to 12 hours

• Duration of Stay in the Emergency Department

  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

  At the time of emergency department discharge or transfer, assessed up to 72 hours from ED admission

• Duration of Hospitalization

  From hospital admission to hospital discharge, assessed up to 14 days.

Study Arms (1)

Non-ST segment elevation ACS

500 adult patients admitted to the emergency department and diagnosed with non-ST segment elevation ACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the emergency department and diagnosed with non-ST segment elevation ACS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (10)

Centre Hospitalier de Haguenau

Haguenau, Bas-Rhin, 67091, France

Location

Centre Hospitalier de Sélestat

Séléstat, Bas-Rhin, 67606, France

Location

Hôpitaux Universitaires de Strasbourg (NHC)

Strasbourg, Bas-Rhin, 67091, France

Location

Hôpital Louis Pasteur

Colmar, Haut-rhin, 68024, France

Location

Hôpital Emilie Muller

Mulhouse, Haut-rhin, 68100, France

Location

Hôpital Maison Blanche

Reims, Marne, 51092, France

Location

CHRU de Nancy

Nancy, Meurthe-et-Moselle, 54000, France

Location

Centre Hospitalier de Pont-à-Mousson

Pont-à-Mousson, Meurthe-et-Moselle, 54701, France

Location

Centre Hospitalier de Toul Saint-Charles

Toul, Meurthe-et-Moselle, 54200, France

Location

CHU de Poitiers, la Milétrie

Poitiers, Vienne, 86000, France

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Society of Cardiology: cardiovascular disease statistics 2021. Eur Heart J. 2022 Feb 22;43(8):716-799. doi: 10.1093/eurheartj/ehab892.

  PMID: 35016208 BACKGROUND

• 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(4):305-338. doi: 10.1016/j.gheart.2018.08.004. Epub 2018 Aug 25. No abstract available.

  PMID: 30154043 BACKGROUND

• 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 syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

  PMID: 37622654 BACKGROUND

• 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 persistent ST-segment elevation. Rev Esp Cardiol (Engl Ed). 2021 Jun;74(6):544. doi: 10.1016/j.rec.2021.05.002. No abstract available. English, Spanish.

  PMID: 34020768 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Angina, Unstable; Death, Sudden, Cardiac; Stroke; Peripheral Arterial Disease; Arrhythmias, Cardiac; Emergencies; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Disease Attributes

Study Officials

• Sabrina GARNIER-KEPKA, Dr

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina GARNIER-KEPKA, Dr

CONTACT

+33369551335; Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

Valérie WILME, Dr

CONTACT

+33388149731; valerie.wilme@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: August 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

FR (10)