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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07824050
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome (ALARM-ACS)
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.
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).
Descripción general del estudio
Estado
Condiciones
- La fibrilación ventricular
- Actividad eléctrica sin pulso
- Asistolia
- Paro cardíaco (CA)
- Taquicardia ventricular (TV)
- Infarto de miocardio (IM)
- Infarto de miocardio sin elevación del ST (NSTEMI)
- Angina Inestable (AI)
- Infarto de miocardio con elevación del segmento ST (IAMCEST)
- Síndromes coronarios agudos (SCA)
Descripción detallada
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?
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Luuk C Otterspoor, Dr. M.D.
- Correo electrónico: luuk.otterspoor@catharinaziekenhuis.nl
Copia de seguridad de contactos de estudio
- Nombre: Maud E Kortman, M.D.
- Número de teléfono: 040 - 239 91 11
- Correo electrónico: maud.kortman@catharinaziekenhuis.nl
Ubicaciones de estudio
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North Brabant
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Eindhoven, North Brabant, Países Bajos, 5623 EJ
- Reclutamiento
- Catharina Hospital Eindhoven
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Contacto:
- Maud E Kortman, M.D.
- Número de teléfono: 040 239 9111
- Correo electrónico: maud.kortman@catharinaziekenhuis.nl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of one (or more) malignant arrhythmia(s) (sustained VT or VF) during admission
Periodo de tiempo: During admission
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Asystole/PEA
Periodo de tiempo: During admission
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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.) |
During admission
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Luuk C Otterspoor, Dr. M.D., Catharina Ziekenhuis Eindhoven
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedad del sistema de conducción cardíaca
- Dolor
- Manifestaciones neurológicas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Arritmias Cardiacas
- Infarto
- Necrosis
- Isquemia miocardica
- Isquemia
- Dolor de pecho
- Angina de pecho
- Taquicardia
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Infarto de miocardio con elevación del ST
- Infarto de miocardio sin elevación del segmento ST
- Paro cardíaco
- Infarto de miocardio
- Taquicardia Ventricular
- El síndrome coronario agudo
- Angina Inestable
- La fibrilación ventricular
Otros números de identificación del estudio
- nWMO-2026.062
- project code 24PPS046 (Otro número de subvención/financiamiento: National collaboration: Holland High Tech, Eindhoven University of Technology, Catharina Hospital Eindhoven, Philips)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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