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Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome

Study acronym: ALARM-ACS
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Eligibility criteria expanded, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07824050
Lead Sponsor Catharina Ziekenhuis Eindhoven
Collaborators: Anna Ziekenhuis Geldrop, St.Jans Gasthuis Weert
Conditions
(from sponsor)
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT), Ventricular Fibrillation, Pulseless Electrical Activity, Asystole, Cardiac Arrest (CA), Myocardial Infarction (MI), Non-ST Elevation (NSTEMI) Myocardial Infarction +2 more
Related terms Acute Coronary Syndrome, Angina, Unstable, Heart Arrest, Myocardial Infarction, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Tachycardia, Ventricular, Ventricular Fibrillation
Enrollment 2,775 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov