Cardiac Arrest Post-Discharge ECG Monitoring

NCT05337371 | Unknown FDA Device

• 1 other identifier: Cardiac Arrest ECG
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Arrest; Arrhythmias, Cardiac; Electrocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation

  Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

• All-cause mortality

  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 within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

• Stroke

  Stroke within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

• Systemic arterial thromboembolism

  Systemic arterial thromboembolism within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

Study Arms (1)

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)

Interventions

ECG patch (Philips ePatch® 2.0) 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.

Philips ePatch® 2.0

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

MeSH Terms

Conditions

Heart Arrest; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carsten Skurk, MD

  Charité - University Hospital Berlin

  STUDY DIRECTOR

• Tharusan Thevathasan, MD

  Charité - University Hospital Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tharusan Thevathasan, MD

CONTACT

+4915774407864; tharusan.thevathasan@charite.de

Carsten Skurk, MD

CONTACT

+49 30 450 513 702; carsten.skurk@charite.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 1, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share