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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Non-ST segment elevation ACS

Trial outcomes

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.

Time frame
During emergency department stay, assessed up to 24 hours

Secondary outcomes

1

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

Occurrence of arrhythmias not immediately life-threatening: atrial fibrillation or flutter, Mobitz type I AV block, first-degree AV block, sinus node dysfunction, or non-sustained VT

Time frame
During emergency department stay, assessed up to 24 hours
2

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

Occurrence of complications such as syncope, presyncope, cardiogenic shock, respiratory distress, or rhythm/conduction disturbances before final diagnosis of NSTE-ACS.

Time frame
Prior to establishing a confirmed diagnosis of NSTE-ACS in the ED, assessed up to 12 hours
3

Duration of Stay in the Emergency Department

Time spent in the emergency department and in the short-stay unit (UHCD) before transfer or discharge.

Time frame
From ED admission to hospital admission, discharge, or UHCD discharge; up to 72 hours
4

Number of patients by disposition at emergency department discharge (home vs. hospital admission and type of admitting service

Disposition of patients: home discharge or hospital admission. For admitted patients, type of service recorded (ICU, coronary care unit, cardiology, internal medicine, short-stay unit, or other).

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

Other outcomes

Sponsors and contacts

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