MyocarditisFlamBerNCT04774549
Inflammatory Cardiomyopathy Bern Registry
An observational study of Myocarditis and Cardiac Sarcoidosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Inflammatory cardiomyopathies are associated with inflammation and impaired function of the heart muscle and encompass myo- and pericarditis and cardiac sarcoidosis. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prediction of outcome is challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis, Cardiac Sarcoidosis, Pericarditis
- How many people
- 1,125 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2005to 31 Dec 2026
- How long will I take part?
- 5 Years
- 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 referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings
Who may be able to join
- Referral to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings
- Ability to provide informed consent (knowledge of project languages),
- Age >18 years
- Exclusions:
- Inability to give consent or existence of a written or documented oral refusal.
- Evidence of coronary artery disease (CAD) by either previous documented medical history, any imaging findings of CAD, or significant epicardial coronary stenosis by invasive coronary angiography;
Show all 9Show fewer
- Evidence of hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, cardiac amyloidosis, Takotsubo cardiomyopathy, Loeffler endocarditis, ventricular noncompaction, cardiac tumor, pulmonary embolism, or persistent severe valve disease.
- Recent cardiovascular surgery or intervention (<90 days prior to CMR)
- Heart transplant
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Cardiology, University Hospital Bern, Inselspital, Bern
Bern, 3010
About this study
Inflammatory cardiomyopathies are associated with inflammation and impaired function of the heart muscle and encompass myo- and pericarditis and cardiac sarcoidosis. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prediction of outcome is challenging. Specifically for myocarditis, it is associated with acute and chronic heart failure and sudden cardiac death.
Cardiac magnetic resonance imaging (CMR) allows imaging of tissue characteristics (i.e. edema and fibrosis). CMR is the primary diagnostic tool in myocarditis and can also be used for differentiating other inflammatory diseases. Beside the presence of edema, also hyperemia/capillary leak, fibrosis and myocardial function can be assessed and quantified.
Read more
Previous studies demonstrated the prognostic role of CMR features beyond traditional markers of LV function, but are limited to smaller cohorts and single-center studies. Furthermore, CMR is a rapidly developing modality and as new features of the modality become available, additional research is needed to identify which combination of parameters optimize risk stratification of this heterogenous inflammatory cardiomyopathy.
Hence, the goal of the registry is to investigate the diagnostic and prognostic role of clinical techniques in inflammatory cardiomyopathies, particularly CMR, and which combination of features provide the highest potential. This analysis will include new advanced CMR techniques but will also assess the role of other techniques that may be more cost-efficient and more widely available, which could be used as a precursor to CMR imaging exams.
Read the detailed description
Inflammatory cardiomyopathies, like myocarditis and cardiac sarcoidosis are associated with inflammation of the heart muscle and or pericardium, which is the likely cause of impaired function of the myocardium. Clinical presentation of these diseases present high variability - from asymptomatic cases to patients with cardiac arrest or severe heart failure. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prognosis remains challenging.
Due to its high spatial resolution and excellent tissue characterization (i.e. the identification of edema and fibrosis), cardiac magnetic resonance imaging (CMR) is the cornerstone in the workup of acute myocarditis and can also be used for differentiating other inflammatory diseases. One of the main criteria for the non-invasive diagnosis of myocarditis has been the Lake Louise Criteria (LLC), where specifically the inclusion of edema and fibrosis as assessed by CMR are necessary to make the diagnosis of myocarditis. The first recommendations released in 2009 indicated 2 of 3 of the following criteria were needed; presence of edema, hyperemia/capillary leak and/or fibrosis. More recently, 2018 updated guidelines are broadened to non-ischemic inflammation to include sarcoidosis, systemic lupus erythematosus and a variety of types of myocarditis. These criteria now include a 2 of 2 criteria with at least one T2-based (edema) and one T1-based (necrosis/fibrosis mostly) criterion, which can be supported by pericardial effusion or systolic LV wall motion abnormalities.
Further, CMR has been reported to be a very strong prognosticator. Traditional markers such as late gadolinium enhancement (LGE) and left ventricular ejection fraction (LVEF), assessed in CMR are outcome predictors for future adverse cardiac events in myocarditis patients. Similar findings have been shown in sarcoidosis as well. However, CMR is a rapidly developing modality and as new features of the modality frequently become available, additional research is needed to identify the best combination of parameters for risk stratification in patients with inflammatory.
CMR feature tracking (CMR-FT) is a developing contrast-free quantitative method that uses cine images in routinely acquired CMR scanning and it is able to quantify systolic and diastolic myocardial deformation in different orientations. CMR-FT has recently been shown to have diagnostic and prognostic value beyond ejection fraction in patients with coronary artery disease or dilated cardiomyopathy. Recently, the investigators could show in collaboration with the Brigham and Women's Hospital at Harvard Medical School that myocardial strain using CMR-FT provides independent and incremental prognostic value over clinical features, ejection fraction and scar (LGE) in patients with myocarditis. CMR-FT may serve as a novel marker to improve risk stratification in myocarditis. Yet this has not yet been investigated yet with parametric mapping techniques, nor with other inflammatory cardiomyopathies.
The goal of the registry is to investigate the diagnostic and prognostic role of clinical techniques in inflammatory cardiomyopathies, particularly CMR, and which combination of features provide the highest potential. This analysis will include new advanced CMR techniques like feature tracking and T1- and T2 mapping but will also assess the role of other techniques that may be more cost-efficient and more widely available, which could be used as a precursor to CMR imaging exams. Further, other imaging modalities such as echocardiography and nuclear imaging (I.e. Positron Emission Tomography) and computed tomography (CT) findings will be assessed and associated with biomarkers and outcome.
- Conditions
- Myocarditis, Cardiac Sarcoidosis, Pericarditis
- Keywords
- Myocarditis, Cardiac sarcoidosis, Pericarditis, CMR feature tracking, Strain, T1 and T2 Mapping, LGE, Outcomes, MACE
- Medical subject headings
- Myocarditis, Pericarditis, Sprains and Strains
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 |
|---|---|---|
| Patients with inflammatory cardiomyopathy | Patients referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac Event)
Global and regional longitudinal (%), circumferential (%) and radial (%) strain measurements are used to quantify LV and RV function. MACE is defined as a composite of sustained ventricular tachycardia, recurrent myocarditis, hospitalization for heart failure and all-cause death all-cause death.
Measured: 5 years
LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE
Global and regional tissue characteristics are assessed by repetitive T1 and T2 mapping (global and regional T1 and T2 time (ms)). MACE is defined as a composite of major cardiovascular endpoints listed above.
Measured: 5 years
Presence of myocardial fibrosis and scar as predictor for MACE
Global and regional myocardial tissue is characterized by gadolinium contrast agent application. The presence and extent (% and total mass (g)) of late gadolinium enhancement is evaluated as a predictor for MACE.
Measured: 5 years
Secondary outcomes (2)
Prognostic impact of sports cessation in acute myocarditis
Sports behaviour is assessed by repetitive self-evaluating questionnaires before and after diagnosis of acute myocarditis. Sports cessation (total vs. partial vs. no cessation) is evaluated as a predictor of MACE.
Measured: Repetitive questionnaire at baseline, after 6 and 12 months as well as after 5 years
Prognostic impact of fragmented QRS in acute myocarditis
Presence and persistence of fragmented QRS as measured by repetitive electrocardiogram is evaluated as a predictor for MACE.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jan 2005
- Primary completionDec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 only
- Time perspective
- Prospective
- Enrolment
- 1,125 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Gräni, MD, PhD, Principal investigator, Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774549
- Sponsor's protocol ID
- 2020-01100
- Other IDs
- 2020-01100
- Acronym
- FlamBer
- Status last verified
- Nov 2024
- First submitted
- 18 Feb 2021
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.
PubMed 29025553Fischer K, Obrist SJ, Erne SA, Stark AW, Marggraf M, Kaneko K, Guensch DP, Huber AT, Greulich S, Aghayev A, Steigner M, Blankstein R, Kwong RY, Grani C. Feature Tracking Myocardial Strain Incrementally Improves Prognostication in Myocarditis Beyond Traditional CMR Imaging Features. JACC Cardiovasc Imaging. 2020 Sep;13(9):1891-1901. doi: 10.1016/j.jcmg.2020.04.025. Epub 2020 Jul 15.
PubMed 32682718Fischer K, Marggraf M, Stark AW, Kaneko K, Aghayev A, Guensch DP, Huber AT, Steigner M, Blankstein R, Reichlin T, Windecker S, Kwong RY, Grani C. Association of ECG parameters with late gadolinium enhancement and outcome in patients with clinical suspicion of acute or subacute myocarditis referred for CMR imaging. PLoS One. 2020 Jan 10;15(1):e0227134. doi: 10.1371/journal.pone.0227134. eCollection 2020.
PubMed 31923225Ciocca N, Brandle D, Riederer L, Fischer K, Schutze J, Wahl A, Tanner G, Guensch DP, Stoyanov K, Garefa C, Pavlicek-Bahlo M, Hundertmark M, Shiri I, Bernhard B, Kwong RY, Grani C. Atrial Function by Long Axis Shortening Enhances Risk Stratification Beyond Traditional CMR Markers in Possible Myocarditis. JACC Cardiovasc Imaging. 2026 Aug;19(8):940-950. doi: 10.1016/j.jcmg.2026.04.006. Epub 2026 May 27.
PubMed 42207065Bernhard B, Tanner G, Garachemani D, Schnyder A, Fischer K, Huber AT, Safarkhanlo Y, Stark AW, Guensch DP, Schutze J, Greulich S, Bastiaansen JAM, Pavlicek-Bahlo M, Benz DC, Kwong RY, Grani C. Predictive value of cardiac magnetic resonance right ventricular longitudinal strain in patients with suspected myocarditis. J Cardiovasc Magn Reson. 2023 Aug 17;25(1):49. doi: 10.1186/s12968-023-00957-6.
PubMed 37587516Bernhard B, Schnyder A, Garachemani D, Fischer K, Tanner G, Safarkhanlo Y, Stark AW, Schutze J, Pavlicek-Bahlo M, Greulich S, Johner C, Wahl A, Benz DC, Kwong RY, Grani C. Prognostic Value of Right Ventricular Function in Patients With Suspected Myocarditis Undergoing Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2023 Jan;16(1):28-41. doi: 10.1016/j.jcmg.2022.08.011. Epub 2022 Oct 19.
PubMed 36599567
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cardiomyopathy Bern Registry
- ClinicalTrials.gov ID
- NCT04774549
- Acronym / sponsor ID
- FlamBer / 2020-01100
- Conditions
- Myocarditis, Cardiac Sarcoidosis, Pericarditis
- Keywords
- Myocarditis, Cardiac sarcoidosis, Pericarditis, CMR feature tracking, Strain, T1 and T2 Mapping, LGE, Outcomes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,125 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Mar 2021 (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.
Inflammatory cardiomyopathies are associated with inflammation and impaired function of the heart muscle and encompass myo- and pericarditis and cardiac sarcoidosis. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prediction of outcome is challenging. Specifically for myocarditis, it is associated with acute and chronic heart failure and sudden cardiac death.
Cardiac magnetic resonance imaging (CMR) allows imaging of tissue characteristics (i.e. edema and fibrosis). CMR is the primary diagnostic tool in myocarditis and can also be used for differentiating other inflammatory diseases. Beside the presence of edema, also hyperemia/capillary leak, fibrosis and myocardial function can be assessed and quantified.
Previous studies demonstrated the prognostic role of CMR features beyond traditional markers of LV function, but are limited to smaller cohorts and single-center studies. Furthermore, CMR is a rapidly developing modality and as new features of the modality become available, additional research is needed to identify which combination of parameters optimize risk stratification of this heterogenous inflammatory cardiomyopathy.
Hence, the goal of the registry is to investigate the diagnostic and prognostic role of clinical techniques in inflammatory cardiomyopathies, particularly CMR, and which combination of features provide the highest potential. This analysis will include new advanced CMR techniques but will also assess the role of other techniques that may be more cost-efficient and more widely available, which could be used as a precursor to CMR imaging exams.
Detailed description
Inflammatory cardiomyopathies, like myocarditis and cardiac sarcoidosis are associated with inflammation of the heart muscle and or pericardium, which is the likely cause of impaired function of the myocardium. Clinical presentation of these diseases present high variability - from asymptomatic cases to patients with cardiac arrest or severe heart failure. Due to the heterogeneity of the clinical manifestations, establishing the diagnosis and prognosis remains challenging.
Due to its high spatial resolution and excellent tissue characterization (i.e. the identification of edema and fibrosis), cardiac magnetic resonance imaging (CMR) is the cornerstone in the workup of acute myocarditis and can also be used for differentiating other inflammatory diseases. One of the main criteria for the non-invasive diagnosis of myocarditis has been the Lake Louise Criteria (LLC), where specifically the inclusion of edema and fibrosis as assessed by CMR are necessary to make the diagnosis of myocarditis. The first recommendations released in 2009 indicated 2 of 3 of the following criteria were needed; presence of edema, hyperemia/capillary leak and/or fibrosis. More recently, 2018 updated guidelines are broadened to non-ischemic inflammation to include sarcoidosis, systemic lupus erythematosus and a variety of types of myocarditis. These criteria now include a 2 of 2 criteria with at least one T2-based (edema) and one T1-based (necrosis/fibrosis mostly) criterion, which can be supported by pericardial effusion or systolic LV wall motion abnormalities.
Further, CMR has been reported to be a very strong prognosticator. Traditional markers such as late gadolinium enhancement (LGE) and left ventricular ejection fraction (LVEF), assessed in CMR are outcome predictors for future adverse cardiac events in myocarditis patients. Similar findings have been shown in sarcoidosis as well. However, CMR is a rapidly developing modality and as new features of the modality frequently become available, additional research is needed to identify the best combination of parameters for risk stratification in patients with inflammatory.
CMR feature tracking (CMR-FT) is a developing contrast-free quantitative method that uses cine images in routinely acquired CMR scanning and it is able to quantify systolic and diastolic myocardial deformation in different orientations. CMR-FT has recently been shown to have diagnostic and prognostic value beyond ejection fraction in patients with coronary artery disease or dilated cardiomyopathy. Recently, the investigators could show in collaboration with the Brigham and Women's Hospital at Harvard Medical School that myocardial strain using CMR-FT provides independent and incremental prognostic value over clinical features, ejection fraction and scar (LGE) in patients with myocarditis. CMR-FT may serve as a novel marker to improve risk stratification in myocarditis. Yet this has not yet been investigated yet with parametric mapping techniques, nor with other inflammatory cardiomyopathies.
The goal of the registry is to investigate the diagnostic and prognostic role of clinical techniques in inflammatory cardiomyopathies, particularly CMR, and which combination of features provide the highest potential. This analysis will include new advanced CMR techniques like feature tracking and T1- and T2 mapping but will also assess the role of other techniques that may be more cost-efficient and more widely available, which could be used as a precursor to CMR imaging exams. Further, other imaging modalities such as echocardiography and nuclear imaging (I.e. Positron Emission Tomography) and computed tomography (CT) findings will be assessed and associated with biomarkers and outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory cardiomyopathy | – | –Patients referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings
Key inclusion criteria (9 listed)
- Referral to CMR for suspected/known inflammatory cardiomyopathy and/or diagnosed inflammatory cardiomyopathy from CMR findings
- Ability to provide informed consent (knowledge of project languages),
- Age >18 years
- Inability to give consent or existence of a written or documented oral refusal.
- Evidence of coronary artery disease (CAD) by either previous documented medical history, any imaging findings of CAD, or significant epicardial coronary stenosis by invasive coronary angiography;
Key exclusion criteria (0 listed)
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
LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac Event)
Time frame: 5 years
Global and regional longitudinal (%), circumferential (%) and radial (%) strain measurements are used to quantify LV and RV function. MACE is defined as a composite of sustained ventricular tachycardia, recurrent myocarditis, hospitalization for heart failure and all-cause death all-cause death.
LV and RV tissue characterization as assessed by T1 and T2 mapping as predictor for MACE
Time frame: 5 years
Global and regional tissue characteristics are assessed by repetitive T1 and T2 mapping (global and regional T1 and T2 time (ms)). MACE is defined as a composite of major cardiovascular endpoints listed above.
Presence of myocardial fibrosis and scar as predictor for MACE
Time frame: 5 years
Global and regional myocardial tissue is characterized by gadolinium contrast agent application. The presence and extent (% and total mass (g)) of late gadolinium enhancement is evaluated as a predictor for MACE.
2 secondary outcomes
Prognostic impact of sports cessation in acute myocarditis
Time frame: Repetitive questionnaire at baseline, after 6 and 12 months as well as after 5 years
Prognostic impact of fragmented QRS in acute myocarditis
Time frame: 5 years
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 5 Nov 2024.
- Background: PubMed 29025553Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.
- Background: PubMed 32682718Fischer K, Obrist SJ, Erne SA, Stark AW, Marggraf M, Kaneko K, Guensch DP, Huber AT, Greulich S, Aghayev A, Steigner M, Blankstein R, Kwong RY, Grani C. Feature Tracking Myocardial Strain Incrementally Improves Prognostication in Myocarditis Beyond Traditional CMR Imaging Features. JACC Cardiovasc Imaging. 2020 Sep;13(9):1891-1901. doi: 10.1016/j.jcmg.2020.04.025. Epub 2020 Jul 15.
- Background: PubMed 31923225Fischer K, Marggraf M, Stark AW, Kaneko K, Aghayev A, Guensch DP, Huber AT, Steigner M, Blankstein R, Reichlin T, Windecker S, Kwong RY, Grani C. Association of ECG parameters with late gadolinium enhancement and outcome in patients with clinical suspicion of acute or subacute myocarditis referred for CMR imaging. PLoS One. 2020 Jan 10;15(1):e0227134. doi: 10.1371/journal.pone.0227134. eCollection 2020.
- Derived from this study: PubMed 42207065Ciocca N, Brandle D, Riederer L, Fischer K, Schutze J, Wahl A, Tanner G, Guensch DP, Stoyanov K, Garefa C, Pavlicek-Bahlo M, Hundertmark M, Shiri I, Bernhard B, Kwong RY, Grani C. Atrial Function by Long Axis Shortening Enhances Risk Stratification Beyond Traditional CMR Markers in Possible Myocarditis. JACC Cardiovasc Imaging. 2026 Aug;19(8):940-950. doi: 10.1016/j.jcmg.2026.04.006. Epub 2026 May 27.
- Derived from this study: PubMed 37587516Bernhard B, Tanner G, Garachemani D, Schnyder A, Fischer K, Huber AT, Safarkhanlo Y, Stark AW, Guensch DP, Schutze J, Greulich S, Bastiaansen JAM, Pavlicek-Bahlo M, Benz DC, Kwong RY, Grani C. Predictive value of cardiac magnetic resonance right ventricular longitudinal strain in patients with suspected myocarditis. J Cardiovasc Magn Reson. 2023 Aug 17;25(1):49. doi: 10.1186/s12968-023-00957-6.
- Derived from this study: PubMed 36599567Bernhard B, Schnyder A, Garachemani D, Fischer K, Tanner G, Safarkhanlo Y, Stark AW, Schutze J, Pavlicek-Bahlo M, Greulich S, Johner C, Wahl A, Benz DC, Kwong RY, Grani C. Prognostic Value of Right Ventricular Function in Patients With Suspected Myocarditis Undergoing Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2023 Jan;16(1):28-41. doi: 10.1016/j.jcmg.2022.08.011. Epub 2022 Oct 19.
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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.
Christoph Gräni, MD, PhD principal investigator
Inselspital, Bern 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 and Cardiac Sarcoidosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 9 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. 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 Switzerland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV (left ventricle) and RV (right ventricle) function as assessed by CMR feature tracking as predictor for MACE (major adverse cardiac Event) (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT04774549, which also lists 6 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 5 Nov 2024.