Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCatharina Ziekenhuis Eindhoven

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients aged 18 years or older with acute coronary syndrome (ACS) (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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,775 Participants
are grouped into 1 trial group
Group A: Patients aged 18 years or older admitted with acute coronary syndrome

Trial outcomes

Primary outcomes

1

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

Time frame
During admission

Secondary outcomes

1

Asystole/PEA

Secondary outcome: Occurrence of one (or more) asystole and/or pulseless electrical activity (PEA) event(s) 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 an asystole/PEA event; only events occurring from the moment of physical hospital admission onward are included.) (Events of asystole or PEA occurring during admission of an ACS patient following cardiac surgery, such as CABG, will not be included.)

Time frame
During admission

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Catharina Ziekenhuis Eindhoven

Lead sponsor

Anna Ziekenhuis Geldrop

Collaborator

St.Jans Gasthuis Weert

Collaborator