跳至主要内容
临床试验/NCT07824050
NCT07824050招募中不适用

Current Relevance of Malignant Cardiac Arrhythmia in Patients Admitted for Acute Coronary Syndrome

Catharina Ziekenhuis Eindhoven1 个研究点 分布在 1 个国家目标入组 2,775 人开始时间: 2026年7月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,775
试验地点
1
主要终点
Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admission

研究概览

简要总结

Patients admitted with an acute coronary syndrome (ACS) are at increased risk of malignant cardiac arrhythmias (MA), such as sustained ventricular tachycardia and ventricular fibrillation. Therefore, patients with ST-elevation myocardial infarction (STEMI) are continuously monitored for a minimum of 24 hours after onset symptoms. Longer monitoring is advised in patients at intermediate to high risk of cardiac arrhythmias, however this risk stratification is not evidence based. Hospitalization, particularly in STEMI patients, is advised for a minimum of 48-72 hours.

AMI care requires a substantial commitment of bed capacity and staff, resulting in high healthcare costs.

In patients who have undergone acute PCI (such as STEMI patients or NSTEMI patients with persistent symptoms), monitoring is primarily aimed at early recognition of MA and signs of persistent or recurrent ischaemia after the intervention.

In NSTEMI/UAP patients still awaiting invasive treatment, the emphasis lies on detecting increasing ischaemia in the as-yet untreated coronary vessel, as well as identifying arrhythmias that may arise as a result.

The true incidence of MA cannot be precisely established due to heterogeneity in the literature, and moreover varies between patients with ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina pectoris, owing to differences in disease process and care pathway.

A better understanding of the current incidence and risk of MA in patients with ACS may contribute to optimizing the monitoring of this patient group, thereby enabling more efficient use of hospital beds and healthcare staff. This prospective quality registry therefore aims to establish the current incidence of MA in ACS patients and to identify potential predictors of MA, while also taking into account other acute complications such as asystole and pulseless electrical activity (PEA).

详细描述

Primary research question:

What is the incidence of malignant arrhythmias (MA, defined as sustained ventricular tachycardia/ventricular fibrillation) during admission in patients with acute coronary syndrome?

Secondary research questions:

What is the incidence of MA during admission in the subgroups:

ST-elevation myocardial infarction (STEMI) Non-ST-elevation myocardial infarction (NSTEMI) Unstable angina pectoris (UAP) What is the temporal relationship of MA occurrence during admission, and can a peak incidence be identified? What are clinical predictors of MA during admission in patients with acute coronary syndrome? How do polymorphic and monomorphic ventricular arrhythmias compare in terms of frequency of occurrence in patients admitted with acute coronary syndrome? What is in-hospital mortality in ACS patients with versus without MA? What is the incidence of asystole and pulseless electrical activity (PEA) during admission in patients with acute coronary syndrome?

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

入选标准

  • Patients aged 18 years or older with acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina pectoris) or out-of-hospital cardiac arrest (OHCA) due to ACS, admitted to the emergency cardiac care unit, emergency department, coronary care unit (CCU), intensive care unit (ICU), or cardiology ward.

排除标准

  • Patients who have indicated that their data may not be used for scientific research or for improving the quality of care.

研究组 & 干预措施

Patients aged 18 years or older admitted with acute coronary syndrome

Patients aged 18 years or older with acute coronary syndrome (ACS) (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction or unstable angina pectoris) or out-of-hospital cardiac arrest (OHCA) due to ACS, admitted to the emergency cardiac care unit, emergency department, coronary care unit (CCU), intensive care unit (ICU), or cardiology ward.

结局指标

主要结局

Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admission

时间窗: During admission

Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admission, defined as from the moment of physical hospital admission until discharge. (For OHCA patients, the index arrhythmic event preceding hospital admission is not counted as a malignant arrhythmia event; only events occurring from the moment of physical hospital admission onward are included.) (Events of sustained VT or VF occurring during admission of an ACS patient following cardiac surgery, such as CABG, will not be included.)

次要结局

  • Asystole/PEA(During admission)

研究者

发起方
Catharina Ziekenhuis Eindhoven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luuk Otterspoor

Dr. M.D.

Catharina Ziekenhuis Eindhoven

研究点 (1)

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