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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2025-09-01
2028-10-01
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Sabrina GARNIER-KEPKA, Dr
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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Centre Hospitalier de Haguenau
Haguenau, Bas-Rhin, France
Centre Hospitalier de Sélestat
Séléstat, Bas-Rhin, France
Hôpitaux Universitaires de Strasbourg (NHC)
Strasbourg, Bas-Rhin, France
Hôpital Louis Pasteur
Colmar, Haut-rhin, France
Hôpital Emilie Muller
Mulhouse, Haut-rhin, France
Hôpital Maison Blanche
Reims, Marne, France
CHRU de Nancy
Nancy, Meurthe-et-Moselle, France
Centre Hospitalier de Pont-à-Mousson
Pont-à-Mousson, Meurthe-et-Moselle, France
Centre Hospitalier de Toul Saint-Charles
Toul, Meurthe-et-Moselle, France
CHU de Poitiers, la Milétrie
Poitiers, Vienne, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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9460
Identifier Type: -
Identifier Source: org_study_id
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