Occurrence of Severe Cardiac Rhythm and Conduction Disturbances in Emergency Department Patients With Non-ST Elevation Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Occurrence of Serious Rhythm or Conduction Disturbances in the Emergency Department
时间窗: 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.
次要结局
- Incidence of Non-Life-Threatening Arrhythmias or Conduction Disorders in the Emergency Department(During emergency department stay, assessed up to 24 hours)
- Number of patients presenting complications prior to a confirmed diagnosis of NSTE-ACS(Prior to establishing a confirmed diagnosis of NSTE-ACS in the ED, assessed up to 12 hours)
- Duration of Stay in the Emergency Department(From ED admission to hospital admission, discharge, or UHCD discharge; up to 72 hours)
- Number of patients by disposition at emergency department discharge (home vs. hospital admission and type of admitting service(At the time of emergency department discharge or transfer, assessed up to 72 hours from ED admission)
- Duration of Hospitalization(From hospital admission to hospital discharge, assessed up to 14 days.)
- Number of patients with all-cause mortality or 5-point major adverse cardiovascular events (5P-MACE) at 30 days(Day 30 post-ED management)
- Clinical features : weight(From admission to discharge from hospital, assessed up to 7 days)
- Clinical features : height(From admission to discharge from hospital, assessed up to 7 days)
- Clinical features : heart rate(From admission to discharge from hospital, assessed up to 7 days)
- Clinical data : blood and arterial pressure(From admission to discharge from hospital, assessed up to 7 days)
- Clinical data : oxygen saturation(From admission to discharge from hospital, assessed up to 7 days)
- Clinical data : temperature(From admission to discharge from hospital, assessed up to 7 days)
- clinical data : capillary blood glucose(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : BNP(From admission to discharge from hospital, assessed up to 7 days)
- Cardiovascular history and risk factors(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : troponin(From admission to discharge from hospital, assessed up to 7 days)
- Biological work-up : NT-proBNP(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : hemoglobin(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : platelets count(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : mean corpuscular volume(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : potassium(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : creatinine(From admission to discharge from hospital, assessed up to 7 days)
- Biological workup : creatinine clearance(From admission to discharge from hospital, assessed up to 7 days)
- Electrocardiogram (ECG)(From admission to discharge from hospital, assessed up to 7 days)