Heart ArrestCArPEMNCT05337371
Cardiac Arrest Post-Discharge ECG Monitoring
An observational study of Heart Arrest and Arrhythmias, Cardiac, run by Charite University, Berlin, Germany.
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
- Conditions the study is for
- Heart Arrest, Arrhythmias, Cardiac, Electrocardiography
- 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.
- Conditions
- Heart Arrest, Arrhythmias, Cardiac, Electrocardiography
- 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 group | Role | What they receive |
|---|---|---|
| Philips ePatch® 2.0 | Patients 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.
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)
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.
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.
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.
Stroke
Incidence of stroke
Measured: Stroke within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
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.
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.
- First posted20 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tharusan Thevathasan, Charite University, Berlin, Germany
- Investigators
- Carsten Skurk, MD, Study director, Charité - University Hospital BerlinTharusan Thevathasan, MD, Principal investigator, Charité - University Hospital Berlin
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Early Cardiac Arrythmias Following Hospital Discharge After Cardiac Arrest Monitored With Philips ePatch® 2.0
- ClinicalTrials.gov ID
- NCT05337371
- Acronym / sponsor ID
- CArPEM / Cardiac Arrest ECG
- Conditions
- Heart Arrest, Arrhythmias, Cardiac, Electrocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Philips ePatch® 2.0 | – | Device: ECG patch (Philips ePatch® 2.0)Patients who are discharged from the hospital with ECG patch (Philips ePatch® 2.0). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to include adult patients who survived cardiac arrest caused by acute myocardial infarction.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Philips ePatch® 2.0 |
Primary outcome
Incidence of serious cardiac arrythmias
Time frame: Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Cardiac arrythmias monitored with Philips ePatch 2.0
6 secondary outcomes
Incidence of sinus arrest, atrial fibrillation, higher degree AV-block, ventricular tachycardia or fibrillation
Time frame: Cardiac arrythmias within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
All-cause mortality
Time frame: Mortality due to any cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Cardiovascular mortality
Time frame: Mortality due to a cardiavascular cause within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Stroke
Time frame: Stroke within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Systemic arterial thromboembolism
Time frame: Systemic arterial thromboembolism within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Unplanned hospitalizations for decompensated heart failure
Time frame: Unplanned hospitalizations for decompensated heart failure within 14 days after hospital discharge from index hospital stay following cardiac arrest event.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Heart Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Skurk, MD study director
Charité - University Hospital Berlin
Tharusan Thevathasan, MD principal investigator
Charité - University Hospital Berlin
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.