NCT07824050

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,775

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Jul 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Apr 2029

Study Start

First participant enrolled

July 14, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2.7 years

First QC Date

September 11, 2026

Last Update Submit

September 11, 2026

Conditions

Keywords

Incidencepredictorstimingin-hospital complicationVentricular TachycardiaVentricular FibrillationCardiac Arrestacute myocardial infarctionacute coronary syndrome

Outcome Measures

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.)

    During admission

Secondary Outcomes (1)

  • Asystole/PEA

    During admission

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Hospital Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeTachycardia, VentricularVentricular FibrillationHeart ArrestMyocardial InfarctionNon-ST Elevated Myocardial InfarctionST Elevation Myocardial InfarctionAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesTachycardiaArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsInfarctionIschemiaNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Luuk C Otterspoor, Dr. M.D.

    Catharina Ziekenhuis Eindhoven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luuk C Otterspoor, Dr. M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. M.D.

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start

July 14, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Sensitive patient data, no permission to be shared externally

Locations