Acute Coronary Syndromes (ACS)ALARM-ACSNCT07824050
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
An observational study of Acute Coronary Syndromes (ACS) and Ventricular Tachycardia (VT), run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT), Ventricular Fibrillation
- How many people
- 2,775 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2026to 1 Apr 2029
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who have indicated that their data may not be used for scientific research or for improving the quality of care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luuk C Otterspoor, Dr. M.D. contact
Netherlands1 site, 1 recruiting
- Recruiting
Catharina Hospital Eindhoven
Eindhoven, North Brabant, 5623 EJ
Maud E Kortman, M.D., 040 239 9111, maud.kortman@catharinaziekenhuis.nl
About this study
Official title: Current Relevance of Malignant Cardiac Arrhythmia in Patients Admitted for 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.
Read more
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).
Read the 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?
- Conditions
- Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT), Ventricular Fibrillation, Pulseless Electrical Activity, Asystole, Cardiac Arrest (CA)
- Keywords
- Incidence, predictors, timing, in-hospital complication, Ventricular Tachycardia, Ventricular Fibrillation, Cardiac Arrest, acute myocardial infarction, acute coronary syndrome
- Medical subject headings
- Acute Coronary Syndrome, Tachycardia, Ventricular, Ventricular Fibrillation, Heart Arrest, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: During admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start14 Jul 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,775 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Anna Ziekenhuis Geldrop, St.Jans Gasthuis Weert
- Responsible party
- Principal investigator, Luuk Otterspoor, Catharina Ziekenhuis Eindhoven
- Investigators
- Luuk C Otterspoor, Dr. M.D., Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824050
- Sponsor's protocol ID
- nWMO-2026.062
- Other IDs
- project code 24PPS046
- Acronym
- ALARM-ACS
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive patient data, no permission to be shared externally
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Relevance of Malignant Cardiac Arrhythmia in Patients Admitted for Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07824050
- Acronym / sponsor ID
- ALARM-ACS / nWMO-2026.062
- Conditions
- Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT), Ventricular Fibrillation, Pulseless Electrical Activity, Asystole, Cardiac Arrest (CA)
- Keywords
- Incidence, predictors, timing, in-hospital complication, Ventricular Tachycardia, Ventricular Fibrillation, Cardiac Arrest, acute myocardial infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,775 participants (estimated)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Anna Ziekenhuis Geldrop, St.Jans Gasthuis Weert
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who have indicated that their data may not be used for scientific research or for improving the quality of care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
1 secondary outcome
Asystole/PEA
Time frame: During admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Sensitive patient data, no permission to be shared externally
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luuk C Otterspoor, Dr. M.D. contact
Luuk C Otterspoor, Dr. M.D. principal investigator
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes (ACS) and Ventricular Tachycardia (VT), run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maud E Kortman, M.D. (040 - 239 91 11, maud.kortman@catharinaziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admission (time frame: During admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.