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

NCT ID: NCT07112547

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2028-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-ST segment elevation ACS

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sabrina GARNIER-KEPKA, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier de Haguenau

Haguenau, Bas-Rhin, France

Site Status

Centre Hospitalier de Sélestat

Séléstat, Bas-Rhin, France

Site Status

Hôpitaux Universitaires de Strasbourg (NHC)

Strasbourg, Bas-Rhin, France

Site Status

Hôpital Louis Pasteur

Colmar, Haut-rhin, France

Site Status

Hôpital Emilie Muller

Mulhouse, Haut-rhin, France

Site Status

Hôpital Maison Blanche

Reims, Marne, France

Site Status

CHRU de Nancy

Nancy, Meurthe-et-Moselle, France

Site Status

Centre Hospitalier de Pont-à-Mousson

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

Site Status

Centre Hospitalier de Toul Saint-Charles

Toul, Meurthe-et-Moselle, France

Site Status

CHU de Poitiers, la Milétrie

Poitiers, Vienne, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sabrina GARNIER-KEPKA, Dr

Role: CONTACT

+33369551335

Valérie WILME, Dr

Role: CONTACT

+33388149731

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Florent BAICRY, Dr

Role: primary

+33606784563

Mathieu OBERLIN, Dr

Role: primary

Kasarra BEN HAMMOUDA, Dr

Role: primary

Marc NOIZET, Dr

Role: primary

+33638931388

Stéphane GENNAI, Dr

Role: primary

+33603590614

Tahar CHOUIHED, Dr

Role: primary

+33383851496

Tahar CHOUIHED, Dr

Role: primary

+33383851496

Tahar CHOUIHED, Dr

Role: primary

+33383851496

Nicolas MARJANOVIC, Dr

Role: primary

+33549444444

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33430516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19549010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35016208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30154043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37622654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34020768 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9460

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.