Myocarditis AcuteAIM-ICDNCT04264455
Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis
An observational study of Myocarditis Acute and Ventricular Arrythmia, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations / arrhythmias / syncope, as well as… Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Myocarditis Acute, Ventricular Arrythmia
- What is being tested?
- Biomonitor, Life Vest and Implantable Cardioverter-Defibrillator (ICD)
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- 24 Oct 2019to 31 Dec 2023
- How long will I take part?
- 2 Years
- 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The groups will be selected from all patients attending the participating hospitals.
Who may be able to join
- secured myocarditis via MRT / endomyocardial biopsy
- ventricular arrhythmias (≥ 5 beats) in the ECG / LZ ECG with clinical indication for a WCD system/ biomonitor/ or the indication for primary/secondary prophylactic ICD implantation
- presence of informed consent
- age >18 and <85 years
Who cannot join
- Participation in another study with an active treatment group
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Wuerzburg University Hospital
Würzburg, Bavaria, 97080
Christina Moser, 004993120139946, moser_c@ukw.de
About this study
Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations / arrhythmias / syncope, as well as (potentially) lethal clinical conditions in the sense of a cardiogenic shock or sudden cardiac death can be found.
In 2015, the European Society of Cardiology (ESC) gave a IIa recommendation for the indication of an ICD vest restoration as "bridging" until the acute phase subsides (possibly normalisation of the left ventricular pump function with reduced probability of malignant cardiac arrhythmia) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability. The Monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis.
The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients diagnosed with myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.
Read the detailed description
Myocarditis is an inflammatory disease of the heart muscle, which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. In the first phase of acute myocarditis direct cell damage, in a second phase myocardial inflammation with additional myocardial damage can be observed. Symptoms vary widely and may include signs of heart failure (dyspnoea, reduced exercise capacity, edema tendency), chest pain, palpitations / arrhythmias / syncope, and (potentially) lethal clinical conditions such as cardiogenic shock or sudden cardiac death. Predictors of increased mortality are syncopes, malignant arrhythmias EF≤35% or heart failure NYHA III-IV. ICD implantation is recommended <3 months after manifestation only in exceptional situations (e.g. following resuscitation). The European Society of Cardiology (ESC) issued a IIa recommendation in 2015 for the indication of ICD vest fitting as "bridging" until the acute phase subsides (possible normalization of left ventricular pumping function with reduced probability of malignant cardiac arrhythmias) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability is necessary. The observation, monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis.
The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients with diagnosed myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.
The study is a prospective multicenter registry study. All potentially stressful measures and examinations such as blood sampling and echocardiography - except for follow-up MRI examinations - are carried out at our centre as standard clinical progress assessment, even independently of participation in the registry. The indication for biomonitor implantation is given after initial screening by means of a 24h-LZ-ECG with positive results (detection of ventricular arrhythmias). The registry study is performed with approved IECDs (Implantable electronic cardiovascular devices: Biomonitor (BioMonitor 2-AF, BioMonitor 3-AF (after release)), Biotronik® ICD) as well as WCD (Wearable Cardioverter Defibrillator, Zoll® LifeVest) and Biotronik® Cardio Messenger. The implantation is carried out exclusively according to the indication/testing guidelines. Thus, there are no risks or disadvantages for the participating patient.
The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias in patients with diagnosed myocarditis and to identify potential predictive factors for their occurrence.
Secondary goal is to analyze the long-term survival and need for heart transplantation and to identify MRI/echocardiographic parameters as determinants of arrhythmias.
- Conditions
- Myocarditis Acute, Ventricular Arrythmia
- Being tested
- Biomonitor, Life Vest, Implantable Cardioverter-Defibrillator (ICD)
- Keywords
- ICD, Life Vest, BioMonitor, Myocarditis, Ventricular Arrythmia
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomonitorDevice
Patients receive a Biomonitor only
Life VestDevice
Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally
Implantable Cardioverter-Defibrillator (ICD)Device
Patients receive an Implantable Cardioverter-Defibrillator (ICD)
| Study group | Role | What they receive |
|---|---|---|
| Biomonitor only | Patients receive a Biomonitor only Receives: Device: Biomonitor; Device: Implantable Cardioverter-Defibrillator (ICD) | |
| Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor | Patients receive a Wearable Cardioverter-Defibrillator (Life Vest) combined with a Biomonitor Receives: Device: Biomonitor; Device: Life Vest; Device: Implantable Cardioverter-Defibrillator (ICD) | |
| ICD Implantation | Patients receive an ICD only Receives: Device: Implantable Cardioverter-Defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring the change of long-term incidence of ventricular arrhythmias in patients with acute myocarditis at several follow-up dates.
The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias and/or sudden cardiac death in patients with diagnosed myocarditis and identify potential predictive factors for their occurrence.
The 2-years incidence of sudden cardiac death and ventricular arrhythmias acquired by the respective device holters in use is investigated.
Measured: 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start24 Oct 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocarditis AcuteStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MVZ Leopoldina GmbH, Brandenburg Medical School Theodor Fontane, Hannover Medical School
- Responsible party
- Principal investigator, PD Dr. Peter Nordbeck, Wuerzburg University Hospital
- Investigators
- Peter Nordbeck, MD, PhD, Principal investigator, Wuerzburg University HospitalJonas Muentze, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264455
- Sponsor's protocol ID
- IT-II-2019
- Acronym
- AIM-ICD
- Status last verified
- Jul 2022
- First submitted
- 19 Dec 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis
- ClinicalTrials.gov ID
- NCT04264455
- Acronym / sponsor ID
- AIM-ICD / IT-II-2019
- Conditions
- Myocarditis Acute, Ventricular Arrythmia
- Keywords
- ICD, Life Vest, BioMonitor, Myocarditis, Ventricular Arrythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- MVZ Leopoldina GmbH, Brandenburg Medical School Theodor Fontane, Hannover Medical School
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Feb 2020 (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.
Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations / arrhythmias / syncope, as well as (potentially) lethal clinical conditions in the sense of a cardiogenic shock or sudden cardiac death can be found.
In 2015, the European Society of Cardiology (ESC) gave a IIa recommendation for the indication of an ICD vest restoration as "bridging" until the acute phase subsides (possibly normalisation of the left ventricular pump function with reduced probability of malignant cardiac arrhythmia) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability. The Monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis.
The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients diagnosed with myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.
Detailed description
Myocarditis is an inflammatory disease of the heart muscle, which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. In the first phase of acute myocarditis direct cell damage, in a second phase myocardial inflammation with additional myocardial damage can be observed. Symptoms vary widely and may include signs of heart failure (dyspnoea, reduced exercise capacity, edema tendency), chest pain, palpitations / arrhythmias / syncope, and (potentially) lethal clinical conditions such as cardiogenic shock or sudden cardiac death. Predictors of increased mortality are syncopes, malignant arrhythmias EF≤35% or heart failure NYHA III-IV. ICD implantation is recommended <3 months after manifestation only in exceptional situations (e.g. following resuscitation). The European Society of Cardiology (ESC) issued a IIa recommendation in 2015 for the indication of ICD vest fitting as "bridging" until the acute phase subsides (possible normalization of left ventricular pumping function with reduced probability of malignant cardiac arrhythmias) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability is necessary. The observation, monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis.
The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients with diagnosed myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.
The study is a prospective multicenter registry study. All potentially stressful measures and examinations such as blood sampling and echocardiography - except for follow-up MRI examinations - are carried out at our centre as standard clinical progress assessment, even independently of participation in the registry. The indication for biomonitor implantation is given after initial screening by means of a 24h-LZ-ECG with positive results (detection of ventricular arrhythmias). The registry study is performed with approved IECDs (Implantable electronic cardiovascular devices: Biomonitor (BioMonitor 2-AF, BioMonitor 3-AF (after release)), Biotronik® ICD) as well as WCD (Wearable Cardioverter Defibrillator, Zoll® LifeVest) and Biotronik® Cardio Messenger. The implantation is carried out exclusively according to the indication/testing guidelines. Thus, there are no risks or disadvantages for the participating patient.
The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias in patients with diagnosed myocarditis and to identify potential predictive factors for their occurrence.
Secondary goal is to analyze the long-term survival and need for heart transplantation and to identify MRI/echocardiographic parameters as determinants of arrhythmias.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biomonitor only | – | Device: Biomonitor, Device: Implantable Cardioverter-Defibrillator (ICD)Patients receive a Biomonitor only |
| Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor | – | Device: Biomonitor, Device: Life Vest, Device: Implantable Cardioverter-Defibrillator (ICD)Patients receive a Wearable Cardioverter-Defibrillator (Life Vest) combined with a Biomonitor |
| ICD Implantation | – | Device: Implantable Cardioverter-Defibrillator (ICD)Patients receive an ICD only |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The groups will be selected from all patients attending the participating hospitals.
Key inclusion criteria (4 listed)
- secured myocarditis via MRT / endomyocardial biopsy
- ventricular arrhythmias (≥ 5 beats) in the ECG / LZ ECG with clinical indication for a WCD system/ biomonitor/ or the indication for primary/secondary prophylactic ICD implantation
- presence of informed consent
- age >18 and <85 years
Key exclusion criteria (2 listed)
- Participation in another study with an active treatment group
- Pregnant or breastfeeding women
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 |
|---|---|---|
| BiomonitorPatients receive a Biomonitor only | Device | Biomonitor only, Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor |
| Life VestPatients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally | Device | Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor |
| Implantable Cardioverter-Defibrillator (ICD)Patients receive an Implantable Cardioverter-Defibrillator (ICD) | Device | Biomonitor only, ICD Implantation, Wearable Cardioverter-Defibrillator (Life Vest) + Biomonitor |
Primary outcome
Monitoring the change of long-term incidence of ventricular arrhythmias in patients with acute myocarditis at several follow-up dates.
Time frame: 24 months follow-up
The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias and/or sudden cardiac death in patients with diagnosed myocarditis and identify potential predictive factors for their occurrence. The 2-years incidence of sudden cardiac death and ventricular arrhythmias acquired by the respective device holters in use is investigated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
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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.
Peter Nordbeck, MD, PhD principal investigator
Wuerzburg University Hospital
Jonas Muentze, MD principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis Acute and Ventricular Arrythmia, run by Wuerzburg University Hospital at 1 site in 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 4 inclusion and 2 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 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Christina Moser (0049 (0) 931 201 39946, moser_c@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring the change of long-term incidence of ventricular arrhythmias in patients with acute myocarditis at several follow-up dates. (time frame: 24 months follow-up). 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 7 Jul 2022.