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Heart ArrestCArPEMNCT05337371

Cardiac Arrest Post-Discharge ECG Monitoring

An observational study of Heart Arrest and Arrhythmias, Cardiac, run by Charite University, Berlin, Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
ECG patch (Philips ePatch® 2.0)
Type of treatment
Medical device
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jun 2022to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Read the 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.

Being tested
ECG patch (Philips ePatch® 2.0)
Medical subject headings
Heart Arrest, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05337371
Study groupRoleWhat they receive
Philips ePatch® 2.0Patients who are discharged from the hospital with ECG patch (Philips ePatch® 2.0).
Receives: Device: ECG patch (Philips ePatch® 2.0)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of serious cardiac arrythmias

    Cardiac arrythmias monitored with Philips ePatch 2.0

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

Secondary outcomes (6)
  1. Incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation

    Cardiac arrythmias monitored with Philips ePatch 2.0

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

  2. All-cause mortality

    Mortality due to any cause

    Measured: Mortality due to any cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

  3. Cardiovascular mortality

    Mortality due to a cardiavascular cause

    Measured: Mortality due to a cardiavascular cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

  4. Stroke

    Incidence of stroke

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

  5. Systemic arterial thromboembolism

    Incidence of systemic arterial thromboembolism

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

  6. Unplanned hospitalizations for decompensated heart failure

    Unplanned hospitalizations for decompensated heart failure

    Measured: Unplanned hospitalizations for decompensated heart failure within 14 days after hospital discharge from index hospital stay following cardiac arrest event.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start1 Jun 2022 (estimated)
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337371
Sponsor's protocol ID
Cardiac Arrest ECG
Acronym
CArPEM
Status last verified
Apr 2022
First submitted
13 Apr 2022
Last updated
20 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Arrest and Arrhythmias, Cardiac, run by Charite University, Berlin, Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tharusan Thevathasan, MD (+4915774407864, tharusan.thevathasan@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious cardiac arrythmias (time frame: Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.

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