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Starting soon Observational

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

NCT07112547 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-09-01
Last updated
2025-08-08

Condition(s) studied

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department — During emergency department stay, assessed up to 24 hours
    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.

Trial sites (10)

FacilityCityRegionStatus
Centre Hospitalier de Haguenau Haguenau Bas-Rhin
Centre Hospitalier de Sélestat Séléstat Bas-Rhin
Hôpitaux Universitaires de Strasbourg (NHC) Strasbourg Bas-Rhin
Hôpital Louis Pasteur Colmar Haut-rhin
Hôpital Emilie Muller Mulhouse Haut-rhin
Hôpital Maison Blanche Reims Marne
CHRU de Nancy Nancy Meurthe-et-Moselle
Centre Hospitalier de Pont-à-Mousson Pont-à-Mousson Meurthe-et-Moselle
Centre Hospitalier de Toul Saint-Charles Toul Meurthe-et-Moselle
CHU de Poitiers, la Milétrie Poitiers Vienne
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07112547 on ClinicalTrials.gov ↗ ← All trials in France