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NCT Number: NCT07112547

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

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).

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Key information

Conditions

Acute Coronary Syndrome Without ST Elevation on Electrocardiogram Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Angina Pectoris Angina, Unstable Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chest Pain Death Death, Sudden Death, Sudden, Cardiac Disease Attributes Emergencies Heart Arrest Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Infarction, Unstable Angina Pectoris, Sudden Cardiac Death, Stroke, Peripheral Artery Disease Myocardial Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Haguenau, Haguenau, Bas-Rhin, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department

    Time frame: 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.

Secondary outcomes

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

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

    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

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

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

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

  3. Duration of Stay in the Emergency Department

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

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

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

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

    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).

  5. Duration of Hospitalization

    Time frame: From hospital admission to hospital discharge, assessed up to 14 days.

    Overall length of stay for hospitalized patients

  6. Number of patients with all-cause mortality or 5-point major adverse cardiovascular events (5P-MACE) at 30 days

    Time frame: Day 30 post-ED management

    This composite outcome includes the number of participants who experience either all-cause death or at least one of the following 5-point major adverse cardiovascular events (5P-MACE) within 30 days:

    • Cardiovascular death
    • Myocardial infarction
    • Stroke or transient ischemic attack (TIA)
    • Hospitalization for heart failure
    • Coronary or peripheral revascularization Outcome events will be assessed through medical records and/or follow-up phone call if needed.

  7. Clinical features : weight

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Weight (kg)

  8. Clinical features : height

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Height (cm)

  9. Clinical features : heart rate

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Heart rate (bpm)

  10. Clinical data : blood and arterial pressure

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    systolic/diastolic blood pressure (mmHg) and mean arterial pressure (mmHg)

  11. Clinical data : oxygen saturation

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    peripheral capillary oxygen saturation (%)

  12. Clinical data : temperature

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Temperature (°C)

  13. clinical data : capillary blood glucose

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Capillary blood glucose g/L

  14. Cardiovascular history and risk factors

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Cardiovascular history and risk factors : questionnaire on medical history and prior related treatments (anticoagulant, antiplatelet agent, analgesic, oxygen therapy, statin, beta blocker, ACE inhibitor, angiotensin II receptor blocker).

  15. Biological workup : troponin

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Troponin (1st, 2nd ; 3rd measurement) (ng/mL)

  16. Biological work-up : NT-proBNP

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    NT-proBNP (ng/mL)

  17. Biological workup : hemoglobin

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    hemoglobin (g/dL)

  18. Biological workup : BNP

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    BNP (ng/mL)

  19. Biological workup : platelets count

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    platelets (10^9/L or Giga/L)

  20. Biological workup : mean corpuscular volume

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    mean corpuscular volume (fL or µm3)

  21. Biological workup : potassium

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    potassium (mmol/L)

  22. Biological workup : creatinine

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    creatinine (µmol/L)

  23. Biological workup : creatinine clearance

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    creatinine clearance (mL/min/1,73m2)

  24. Electrocardiogram (ECG)

    Time frame: From admission to discharge from hospital, assessed up to 7 days

    Electrocardiogram (ECG) : presence or absence of ST elevation, T wave inversion, pathological

Study contacts

Contact information is provided by the study sponsor or research team.

Sabrina GARNIER-KEPKA, Dr

CONTACT

[email protected]

+33369551335

Valérie WILME, Dr

CONTACT

[email protected]

+33388149731

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: SurvSCA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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