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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07112547
Acronym
SurvSCA
Enrollment
500
Registered
2025-08-08
Start date
2025-09-01
Completion date
2028-10-01
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non-ST Segment Elevation Acute Coronary Syndrome, Cardiac Arrhythmias, Heart Conduction System Disease, Hospital Emergency Service, Electrocardiographic monitoring, Cardiovascular diseases

Brief 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).

Interventions

None listed

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency DepartmentDuring emergency department stay, assessed up to 24 hoursOccurrence 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

MeasureTime frameDescription
Incidence of Non-Life-Threatening Arrhythmias or Conduction Disorders in the Emergency DepartmentDuring emergency department stay, assessed up to 24 hoursOccurrence 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
Number of patients presenting complications prior to a confirmed diagnosis of NSTE-ACSPrior to establishing a confirmed diagnosis of NSTE-ACS in the ED, assessed up to 12 hoursOccurrence of complications such as syncope, presyncope, cardiogenic shock, respiratory distress, or rhythm/conduction disturbances before final diagnosis of NSTE-ACS.
Duration of Stay in the Emergency DepartmentFrom ED admission to hospital admission, discharge, or UHCD discharge; up to 72 hoursTime spent in the emergency department and in the short-stay unit (UHCD) before transfer or discharge.
Number of patients by disposition at emergency department discharge (home vs. hospital admission and type of admitting serviceAt the time of emergency department discharge or transfer, assessed up to 72 hours from ED admissionDisposition 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).
Duration of HospitalizationFrom hospital admission to hospital discharge, assessed up to 14 days.Overall length of stay for hospitalized patients
Clinical data : temperatureFrom admission to discharge from hospital, assessed up to 7 daysTemperature (°C)
Number of patients with all-cause mortality or 5-point major adverse cardiovascular events (5P-MACE) at 30 daysDay 30 post-ED managementThis 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: 1. Cardiovascular death 2. Myocardial infarction 3. Stroke or transient ischemic attack (TIA) 4. Hospitalization for heart failure 5. Coronary or peripheral revascularization Outcome events will be assessed through medical records and/or follow-up phone call if needed.
Clinical features : weightFrom admission to discharge from hospital, assessed up to 7 daysWeight (kg)
Clinical features : heightFrom admission to discharge from hospital, assessed up to 7 daysHeight (cm)
Clinical features : heart rateFrom admission to discharge from hospital, assessed up to 7 daysHeart rate (bpm)
Clinical data : blood and arterial pressureFrom admission to discharge from hospital, assessed up to 7 dayssystolic/diastolic blood pressure (mmHg) and mean arterial pressure (mmHg)
clinical data : capillary blood glucoseFrom admission to discharge from hospital, assessed up to 7 daysCapillary blood glucose g/L
Cardiovascular history and risk factorsFrom admission to discharge from hospital, assessed up to 7 daysCardiovascular 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).
Biological workup : troponinFrom admission to discharge from hospital, assessed up to 7 daysTroponin (1st, 2nd ; 3rd measurement) (ng/mL)
Biological work-up : NT-proBNPFrom admission to discharge from hospital, assessed up to 7 daysNT-proBNP (ng/mL)
Biological workup : hemoglobinFrom admission to discharge from hospital, assessed up to 7 dayshemoglobin (g/dL)
Biological workup : BNPFrom admission to discharge from hospital, assessed up to 7 daysBNP (ng/mL)
Biological workup : platelets countFrom admission to discharge from hospital, assessed up to 7 daysplatelets (10\^9/L or Giga/L)
Biological workup : mean corpuscular volumeFrom admission to discharge from hospital, assessed up to 7 daysmean corpuscular volume (fL or µm3)
Biological workup : potassiumFrom admission to discharge from hospital, assessed up to 7 dayspotassium (mmol/L)
Biological workup : creatinineFrom admission to discharge from hospital, assessed up to 7 dayscreatinine (µmol/L)
Biological workup : creatinine clearanceFrom admission to discharge from hospital, assessed up to 7 dayscreatinine clearance (mL/min/1,73m2)
Electrocardiogram (ECG)From admission to discharge from hospital, assessed up to 7 daysElectrocardiogram (ECG) : presence or absence of ST elevation, T wave inversion, pathological
Clinical data : oxygen saturationFrom admission to discharge from hospital, assessed up to 7 daysperipheral capillary oxygen saturation (%)

Countries

France

Contacts

Primary ContactSabrina GARNIER-KEPKA, Dr
Sabrina.GARNIER-KEPKA@chru-strasbourg.fr+33369551335
Backup ContactValérie WILME, Dr
valerie.wilme@chru-strasbourg.fr+33388149731

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026