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Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07824050
Acronym
ALARM-ACS
Enrollment
2775
Registered
2026-09-17
Start date
2026-07-14
Completion date
2029-04-01
Last updated
2026-09-17

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

Conditions

Acute Coronary Syndromes (ACS), Asystole, Cardiac Arrest (CA), Myocardial Infarction (MI), Non-ST Elevation (NSTEMI) Myocardial Infarction, Pulseless Electrical Activity, ST Elevation (STEMI) Myocardial Infarction, Unstable Angina (UA), Ventricular Fibrillation, Ventricular Tachycardia (VT)

Keywords

Incidence, predictors, timing, in-hospital complication, Ventricular Tachycardia, Ventricular Fibrillation, Cardiac Arrest, acute myocardial infarction, acute coronary syndrome

Brief summary

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).

Detailed description

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?

Interventions

None listed

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER
Anna Ziekenhuis Geldrop
CollaboratorUNKNOWN
St.Jans Gasthuis Weert
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admissionDuring admissionOccurrence 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

MeasureTime frameDescription
Asystole/PEADuring admissionSecondary 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.)

Countries

Netherlands

Contacts

CONTACTMaud E Kortman, M.D.
maud.kortman@catharinaziekenhuis.nl040 - 239 91 11
CONTACTLuuk C Otterspoor, Dr. M.D.
luuk.otterspoor@catharinaziekenhuis.nl
PRINCIPAL_INVESTIGATORLuuk C Otterspoor, Dr. M.D.

Catharina Ziekenhuis Eindhoven

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026