Clinical trial NCT05337371: Cardiac Arrest Post-Discharge ECG Monitoring
Official title: Incidence of Early Cardiac Arrythmias Following Hospital Discharge After Cardiac Arrest Monitored With Philips ePatch® 2.0
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Arrest
Arrhythmias, Cardiac
Electrocardiography
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to include adult patients who survived cardiac arrest caused by acute myocardial infarction.

Brief summary: The primary aim is to conduct a prospective observational cohort study to analyze the incidence of serious arrhythmic events that occur within 14 days after hospital discharge in patients who had been hospitalized for cardiac arrest caused by acute myocardial infarction. Cardiac arrythmias following hospital dischagre will be detected with Philips ePatch® 2.0 for 14 days.

Detailed description: Approximately 60,000 patients suffer from out-of-hospital cardiac arrest in Germany every year. Areas of myocardial ischemia may induce cardiac arrythmias, such as atrial fibrillation, ventricular tachycardia or ventricular fibrillation, which are known arrhythmic complications following cardiac arrest. Additionally, an imbalance in electrolytes as well as an increased use of inotropic or vasoactive medication as part of post-resuscitation care in the intensive care unit (ICU) may further increase the risk of cardiac arrythmias. 80% of cardiac arrythmias occur within 24 hours after cardiac arrest in the ICU. Patients with cardiac arrythmias following cardiac arrest have an increased mortality risk. Therefore, patients with cardiac arrest are monitored closely with telemetric monitors in the hospital, revascularized early and treated with beta-blockers, statins and renin-angiotensin-aldosterone antagonists to enhance myocardial remodeling and to decrease the rate of cardiac arrythmias. As soon as the patients are discharged from the hospital, no telemetric ECG monitoring can be provided. Therefore, the incidence of early cardiac arrythmias, which occur within 14 days after hospital discharge after treatment for cardiac arrest, remains unclear.

We plan to include 100 adult patients (≥18 years and ≤80 years) who survived cardiac arrest caused by acute myocardial infarction within the past 10 days. Patients with a left-ventricular ejection fraction between 36 to 50% and with sinus rhythm at the time of hospital discharge will be enrolled in this study. Patients who are suitable for implantable cardioverter-defibrillators (ICD) or pacemakers, with known paroxysmal or persistent atrial fibrillation, known inability to comply with follow-up or known pregnancy will not be enrolled.

Primary aim: The primary aim is to conduct a prospective observational cohort study to analyze the incidence of serious arrhythmic events that occur within 14 days after hospital discharge in patients who had been hospitalized for cardiac arrest caused by acute myocardial infarction. Cardiac arrythmias following hospital dischagre will be detected with Philips ePatch® 2.0 for 14 days.

Secondary aims: The secondary aim is to analzye the incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation, all-cause mortality, cardiovascular mortality, stroke, systemic arterial thromboembolism and unplanned hospitalizations for decompensated heart failure within 14 days after discharge from the index hospital stay.

Eligibility criteria: Inclusion Criteria:

* Age: 18-80 years
* Cardiac arrest due to acute myocardial infarction
* Cardiac arrest ≤10 days ago
* Left-ventricular ejecion fraction at hospital discharge: 36-50%
* Sinus rhythm at hospital discharge
* Optimal medical therapy

Exclusion Criteria:

* Non-adult patients
* Cardiac arrest due to another cause other than acute myocardial infarction
* Philips ePatch® 2.0 not applicable
* ICD or pacemaker indication
* Known paroxysmal or persistent atrial fibrillation
* Inability to comply with follow-up- Pregnancy

Primary outcomes:
measure: Incidence of serious cardiac arrythmias
timeFrame: Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Secondary outcomes:
measure: Incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation
timeFrame: Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
measure: All-cause mortality
timeFrame: Mortality due to any cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
measure: Cardiovascular mortality
timeFrame: Mortality due to a cardiavascular cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
measure: Stroke
timeFrame: Stroke within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
measure: Systemic arterial thromboembolism
timeFrame: Systemic arterial thromboembolism within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
measure: Unplanned hospitalizations for decompensated heart failure
timeFrame: Unplanned hospitalizations for decompensated heart failure within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Other outcomes:
Locations:
Study officials:
affiliation: Charité - University Hospital Berlin
name: Carsten Skurk, MD
role: STUDY_DIRECTOR
affiliation: Charité - University Hospital Berlin
name: Tharusan Thevathasan, MD
role: PRINCIPAL_INVESTIGATOR
References: