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NCT Number: NCT07824050

Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome

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).

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Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Angina Pectoris Angina, Unstable Arrhythmias, Cardiac Asystole Cardiac Arrest (CA) Cardiac Conduction System Disease Cardiovascular Diseases Chest Pain Heart Arrest Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Infarction (MI) Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST Elevation (NSTEMI) Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pulseless Electrical Activity ST Elevation (STEMI) Myocardial Infarction ST Elevation Myocardial Infarction Signs and Symptoms Tachycardia Tachycardia, Ventricular Unstable Angina (UA) Vascular Diseases Ventricular Fibrillation Ventricular Tachycardia (VT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location status: Recruiting

Location contact

Maud E Kortman, M.D.

CONTACT

[email protected]

040 239 9111

About this study

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?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.)

Secondary outcomes

  1. Asystole/PEA

    Time frame: During admission

    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.)

Study contacts

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

Luuk C Otterspoor, Dr. M.D.

CONTACT

[email protected]

Maud E Kortman, M.D.

CONTACT

[email protected]

040 - 239 91 11

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Anna Ziekenhuis Geldrop
  • St.Jans Gasthuis Weert

Registry information

Official study title

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

Acronym: ALARM-ACS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

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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