Cardiac Arrest Post-Discharge ECG Monitoring

NCT ID: NCT05337371

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-05-01

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.

Conditions

Heart Arrest; Arrhythmias, Cardiac; Electrocardiography

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Philips ePatch® 2.0

Patients who are discharged from the hospital with ECG patch (Philips ePatch® 2.0).

ECG patch (Philips ePatch® 2.0)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Tharusan Thevathasan

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carsten Skurk, MD

Role: STUDY_DIRECTOR

Charité - University Hospital Berlin

Tharusan Thevathasan, MD

Role: PRINCIPAL_INVESTIGATOR

Charité - University Hospital Berlin

Central Contacts

Tharusan Thevathasan, MD

Role: CONTACT

tharusan.thevathasan@charite.de

+4915774407864

Carsten Skurk, MD

Role: CONTACT

carsten.skurk@charite.de

+49 30 450 513 702

Other Identifiers

Cardiac Arrest ECG

Identifier Type: -

Identifier Source: org_study_id