Cardiac Arrest Post-Discharge ECG Monitoring (CArPEM)

Incidence of Early Cardiac Arrythmias Following Hospital Discharge After Cardiac Arrest Monitored With Philips ePatch® 2.0

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arrhythmias, Cardiac; Heart Arrest; Electrocardiography
• Intervention / Treatment: Device: ECG patch (Philips ePatch® 2.0)

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tharusan Thevathasan, MD; Phone Number: +4915774407864; Email: tharusan.thevathasan@charite.de
• Study Contact Backup: Name: Carsten Skurk, MD; Phone Number: +49 30 450 513 702; Email: carsten.skurk@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We plan to include adult patients who survived cardiac arrest caused by acute myocardial infarction.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Philips ePatch® 2.0; Patients who are discharged from the hospital with ECG patch (Philips ePatch® 2.0).	Device: ECG patch (Philips ePatch® 2.0); The ECG patch will be put on the patients chest to monitor cardiac activity for a total time period of 14 days after cardiac arrest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of serious cardiac arrythmias	Cardiac arrythmias monitored with Philips ePatch 2.0	Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation	Cardiac arrythmias monitored with Philips ePatch 2.0	Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
All-cause mortality	Mortality due to any cause	Mortality due to any cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Cardiovascular mortality	Mortality due to a cardiavascular cause	Mortality due to a cardiavascular cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Stroke	Incidence of stroke	Stroke within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Systemic arterial thromboembolism	Incidence of systemic arterial thromboembolism	Systemic arterial thromboembolism within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Unplanned hospitalizations for decompensated heart failure	Unplanned hospitalizations for decompensated heart failure	Unplanned hospitalizations for decompensated heart failure within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Study Director: Carsten Skurk, MD, Charite - University Hospital Berlin; Principal Investigator: Tharusan Thevathasan, MD, Charite - University Hospital Berlin

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Arrest
• Other Study ID Numbers: Cardiac Arrest ECG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No