MyocarditisMYOCARDITIS-VTNCT06730607
Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study
An observational study of Myocarditis and Ventricular Arrhythmia, run by Centro Medico Teknon at 3 sites in 2 countries.
Trial summary
Ventricular arrhythmias (VAs) are frequently associated with structural heart diseases (SHD) such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. Myocardial fibrotic tissue plays a central role in the genesis and the maintenance of re-entrant VAs associated with post-myocarditis sequelae and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis, Ventricular Arrhythmia
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Dec 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previous myocarditis and a cardiac magnetic resonance performed at least 6 months after the diagnosis
Who may be able to join
- Age > 18 years.
- Myocarditis diagnosis > 6 months before the inclusion in the study.
- Signed informed consent.
- CMR performed > 6 months after myocarditis diagnosis
Who cannot join
- Age < 18 years.
- Pregnancy.
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Active myocarditis
- Myocarditis diagnosis < 6 months
- Previously documented sustained ventricular arrhythmias.
Show all 9Show fewer
- Impossibility or contraindications to undergo LGE-CMR.
- Concomitant investigation treatments.
- Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, Pisa, 56126
Giulio Zucchelli, MD, PhD, 677851132, zucchelli76@gmail.com
- Recruiting
Humanitas Research Hospital
Rozzano, Milan, 20089
Diego Penela Maceda, MD, PhD, 647628720, dpenela30@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Teknon Medical Center
Barcelona, Barcelona, 08022
Antonio Berruezo, MD, PhD, 677851132, antonio.berruezo@quironsalud.es
About this study
Official title: Image-Based Prediction of Ventricular Tachycardia Events in Post-Myocarditis Patients: an International Multicenter Case-control Study
Ventricular arrhythmias (VAs) are frequently associated with structural heart diseases (SHD) such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. Myocardial fibrotic tissue plays a central role in the genesis and the maintenance of re-entrant VAs associated with post-myocarditis sequelae and late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful tool for the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Moreover, a post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain) allows to analyze the CMR-derived data and to characterize the scar architecture, differentiating between dense (scar core zone) and more diffuse (border zone [BZ]) fibrosis, and identifying the BZ channels (BZCs) that are strands of healthy myocardial tissue within zones of unexcitable tissue and connect areas of normal myocardium. It was described that BZCs could serve as slow-conducting reentrant pathways and are critical to entail VA in ischemic and non-ischemic heart disease. However, the pathophysiological role and the correlation between scar architecture and VAs in post-myocarditis patients is yet to be defined.
To date, the standard-of-care evaluation for primary prevention implantable cardioverter-defibrillator (ICD) therapy is LVEF-based, leading to the fact that the contemporary rate of appropriated therapies is very low. Moreover, events may also occur in patients with normal to moderately depressed LVEF, which is particularly relevant, as it constitutes the most prevalent population of patients exposed to an increased risk of VAs. Multiple studies reported that LGE at CMR is a strong and specific predictor of VT occurrence and sudden death in post-myocarditis patients. There were reported cases in which even after the normalization of LVEF, the extension of LGE, the scar architecture, and the presence of BZCs at cMR analysis are determinants of the arrhythmic risk in post-myocarditis patients.
The Investigators sought to evaluate the usefulness of CMR-derived scar architecture analysis to predict the occurrence of VT events in an international, multicenter, case-control study on unselected post-myocarditis patients without previous arrhythmia evidence. Aim of the study is also to assess the net reclassification improvement (NRI) for the indication of primary prevention ICD implantation using CMR data and post-processing data as compared to LVEF-based indication
Read the detailed description
Research hypothesis
The composite outcome is:
- sudden cardiac death, sustained VT, syncopal VT or appropriate ICD therapy (ATP and/or shock) in ICD carriers in primary prevention, or
- sudden cardiac death, sustained VT, syncopal VT detected by any diagnostic test (i.e., 24 h Holter monitoring, prolonged Holter monitoring, urgency ECG etc.) in no ICD-carriers.
Our research hypothesis is that the composite outcome will be higher in those patients with greater scar mass and BZC mass.
Primary objective To analyze the composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented by any diagnostic method) in post-myocarditis patients with no previous arrhythmia evidence, according to their risk classification by means of BZC mass.
Secondary objectives
To analyze the relationship between the primary outcome and other variables:
- LVEF
- Scar mass
- BZ mass
- Core mass
- Presence and number of tissue channels within the scar, as detected by cardiac CT
- Age
- Time since myocarditis
- Conditions
- Myocarditis, Ventricular Arrhythmia
- Keywords
- myocarditis, ventricular arrhythmias, sudden cardiac death, cardiac magnetic resonance
- Medical subject headings
- Myocarditis, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases: patients with sudden cardiac death or sustained ventricular arrhythmias during the follow-up | Inclusion criteria Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age > 18 years. 2. Myocarditis diagnosis > 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed > 6 months after myocarditis diagnosis Exclusion criteria Patients will be excluded if they meet ANY of the following exclusion criteria: * Age < 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis < 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study. | |
| Controls:patients without sudden cardiac death or sustained ventricular arrhythmias during follow-up | Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age > 18 years. 2. Myocarditis diagnosis > 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed > 6 months after myocarditis diagnosis Patients will be excluded if they meet ANY of the following exclusion criteria: * Age < 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis < 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting one of sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy.
The primary endpoint will be the clinical composite of sudden cardiac death or any sustained ventricular arrhythmia.
The endpoint will be retrospectively correlated with the cMR-derived findings.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start2 Dec 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730607
- Sponsor's protocol ID
- MYOCARDITIS-VT
- Acronym
- MYOCARDITIS-VT
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acosta J, Fernandez-Armenta J, Borras R, Anguera I, Bisbal F, Marti-Almor J, Tolosana JM, Penela D, Andreu D, Soto-Iglesias D, Evertz R, Matiello M, Alonso C, Villuendas R, de Caralt TM, Perea RJ, Ortiz JT, Bosch X, Serra L, Planes X, Greiser A, Ekinci O, Lasalvia L, Mont L, Berruezo A. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study. JACC Cardiovasc Imaging. 2018 Apr;11(4):561-572. doi: 10.1016/j.jcmg.2017.04.021. Epub 2017 Aug 2.
PubMed 28780194Jauregui B, Soto-Iglesias D, Penela D, Acosta J, Fernandez-Armenta J, Linhart M, Ordonez A, San Antonio R, Teres C, Chauca A, Carreno JM, Scherer C, Falasconi G, Prat-Gonzalez S, Perea RJ, Mont L, Bosch X, Ortiz-Perez JT, Berruezo A. Cardiovascular magnetic resonance determinants of ventricular arrhythmic events after myocardial infarction. Europace. 2022 Jul 15;24(6):938-947. doi: 10.1093/europace/euab275.
PubMed 34849726Di Marco A, Brown P, Mateus G, Faga V, Nucifora G, Claver E, Viedma J, Galvan F, Bradley J, Dallaglio PD, de Frutos F, Miller CA, Comin-Colet J, Anguera I, Schmitt M. Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA class I patients with non-ischaemic cardiomyopathy. Eur J Heart Fail. 2023 May;25(5):740-750. doi: 10.1002/ejhf.2793. Epub 2023 Feb 22.
PubMed 36781200Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.
PubMed 32138965
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Based Prediction of Ventricular Tachycardia Events in Post-Myocarditis Patients: an International Multicenter Case-control Study
- ClinicalTrials.gov ID
- NCT06730607
- Acronym / sponsor ID
- MYOCARDITIS-VT / MYOCARDITIS-VT
- Conditions
- Myocarditis, Ventricular Arrhythmia
- Keywords
- myocarditis, ventricular arrhythmias, sudden cardiac death, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (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.
Ventricular arrhythmias (VAs) are frequently associated with structural heart diseases (SHD) such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. Myocardial fibrotic tissue plays a central role in the genesis and the maintenance of re-entrant VAs associated with post-myocarditis sequelae and late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful tool for the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Moreover, a post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain) allows to analyze the CMR-derived data and to characterize the scar architecture, differentiating between dense (scar core zone) and more diffuse (border zone [BZ]) fibrosis, and identifying the BZ channels (BZCs) that are strands of healthy myocardial tissue within zones of unexcitable tissue and connect areas of normal myocardium. It was described that BZCs could serve as slow-conducting reentrant pathways and are critical to entail VA in ischemic and non-ischemic heart disease. However, the pathophysiological role and the correlation between scar architecture and VAs in post-myocarditis patients is yet to be defined.
To date, the standard-of-care evaluation for primary prevention implantable cardioverter-defibrillator (ICD) therapy is LVEF-based, leading to the fact that the contemporary rate of appropriated therapies is very low. Moreover, events may also occur in patients with normal to moderately depressed LVEF, which is particularly relevant, as it constitutes the most prevalent population of patients exposed to an increased risk of VAs. Multiple studies reported that LGE at CMR is a strong and specific predictor of VT occurrence and sudden death in post-myocarditis patients. There were reported cases in which even after the normalization of LVEF, the extension of LGE, the scar architecture, and the presence of BZCs at cMR analysis are determinants of the arrhythmic risk in post-myocarditis patients.
The Investigators sought to evaluate the usefulness of CMR-derived scar architecture analysis to predict the occurrence of VT events in an international, multicenter, case-control study on unselected post-myocarditis patients without previous arrhythmia evidence. Aim of the study is also to assess the net reclassification improvement (NRI) for the indication of primary prevention ICD implantation using CMR data and post-processing data as compared to LVEF-based indication
Detailed description
Research hypothesis
The composite outcome is:
- sudden cardiac death, sustained VT, syncopal VT or appropriate ICD therapy (ATP and/or shock) in ICD carriers in primary prevention, or
- sudden cardiac death, sustained VT, syncopal VT detected by any diagnostic test (i.e., 24 h Holter monitoring, prolonged Holter monitoring, urgency ECG etc.) in no ICD-carriers.
Our research hypothesis is that the composite outcome will be higher in those patients with greater scar mass and BZC mass.
Primary objective To analyze the composite outcome of sudden cardiac death or sustained ventricular tachycardia (either treated by an ICD or documented by any diagnostic method) in post-myocarditis patients with no previous arrhythmia evidence, according to their risk classification by means of BZC mass.
Secondary objectives
To analyze the relationship between the primary outcome and other variables:
- LVEF
- Scar mass
- BZ mass
- Core mass
- Presence and number of tissue channels within the scar, as detected by cardiac CT
- Age
- Time since myocarditis
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases: patients with sudden cardiac death or sustained ventricular arrhythmias during the follow-up | – | –Inclusion criteria Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age > 18 years. 2. Myocarditis diagnosis > 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed > 6 months after myocarditis diagnosis Exclusion criteria Patients will be excluded if they meet ANY of the following exclusion criteria: * Age < 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis < 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study. |
| Controls:patients without sudden cardiac death or sustained ventricular arrhythmias during follow-up | – | –Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age > 18 years. 2. Myocarditis diagnosis > 6 months before the inclusion in the study. 3. Signed informed consent. 4. CMR performed > 6 months after myocarditis diagnosis Patients will be excluded if they meet ANY of the following exclusion criteria: * Age < 18 years. * Pregnancy. * Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.) * Active myocarditis * Myocarditis diagnosis < 6 months * Previously documented sustained ventricular arrhythmias. * Impossibility or contraindications to undergo LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previous myocarditis and a cardiac magnetic resonance performed at least 6 months after the diagnosis
Key inclusion criteria (4 listed)
- Age > 18 years.
- Myocarditis diagnosis > 6 months before the inclusion in the study.
- Signed informed consent.
- CMR performed > 6 months after myocarditis diagnosis
Key exclusion criteria (9 listed)
- Age < 18 years.
- Pregnancy.
- Other concomitant structural heart diseases (e.g. congenital, non-ischemic, etc.)
- Active myocarditis
- Myocarditis diagnosis < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients presenting one of sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy.
Time frame: 2 years
The primary endpoint will be the clinical composite of sudden cardiac death or any sustained ventricular arrhythmia. The endpoint will be retrospectively correlated with the cMR-derived findings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Background: PubMed 28780194Acosta J, Fernandez-Armenta J, Borras R, Anguera I, Bisbal F, Marti-Almor J, Tolosana JM, Penela D, Andreu D, Soto-Iglesias D, Evertz R, Matiello M, Alonso C, Villuendas R, de Caralt TM, Perea RJ, Ortiz JT, Bosch X, Serra L, Planes X, Greiser A, Ekinci O, Lasalvia L, Mont L, Berruezo A. Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study. JACC Cardiovasc Imaging. 2018 Apr;11(4):561-572. doi: 10.1016/j.jcmg.2017.04.021. Epub 2017 Aug 2.
- Background: PubMed 34849726Jauregui B, Soto-Iglesias D, Penela D, Acosta J, Fernandez-Armenta J, Linhart M, Ordonez A, San Antonio R, Teres C, Chauca A, Carreno JM, Scherer C, Falasconi G, Prat-Gonzalez S, Perea RJ, Mont L, Bosch X, Ortiz-Perez JT, Berruezo A. Cardiovascular magnetic resonance determinants of ventricular arrhythmic events after myocardial infarction. Europace. 2022 Jul 15;24(6):938-947. doi: 10.1093/europace/euab275.
- Background: PubMed 36781200Di Marco A, Brown P, Mateus G, Faga V, Nucifora G, Claver E, Viedma J, Galvan F, Bradley J, Dallaglio PD, de Frutos F, Miller CA, Comin-Colet J, Anguera I, Schmitt M. Late gadolinium enhancement and the risk of ventricular arrhythmias and sudden death in NYHA class I patients with non-ischaemic cardiomyopathy. Eur J Heart Fail. 2023 May;25(5):740-750. doi: 10.1002/ejhf.2793. Epub 2023 Feb 22.
- Background: PubMed 32138965Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.
- Individual participant dataSharing planned: No
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Ventricular Arrhythmia, run by Centro Medico Teknon at 3 sites in 2 countries.
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 9 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients presenting one of sudden cardiac death, sustained ventricular arrhythmia, or defibrillator therapy. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06730607, which also lists 4 linked publications.
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 12 Dec 2024.