CardiomyopathiesMagMaNCT06689098
Magnetocardiography as a Diagnostic Screening Tool for Myocarditis and Other Types of Cardiomyopathy
An observational study of Cardiomyopathies, run by German Heart Institute at 1 site in Germany.
Trial summary
Accurate and rapid screening is an unmet medical need to address the increasing demand for advanced diagnostic workup in patients with suspected cardiomyopathy. Due to an overwhelmed health care system, advanced imaging is not always immediately available leading to underdiagnosis and progression of cardiomyopathies… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Magnetocardiography scan
- How many people
- 330 participants
- Where
- 1 siteGermany
- Study dates
- 14 Dec 2022to 1 Dec 2024
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The healthy controls do not have any history of cardiac disease. Standard examiniations ensure that there are no undiagnosed conditions.
Who may be able to join
- Patients with angina-like symptoms after exclusion of coronary artery disease
Who cannot join
- Presence of intracardiac metal devices and prior treatment with immunosuppressants
Trial locations and contacts
1 site in 1 country.
Germany1 site
Deutsches Herzzentrum der Charité
Steglitz, State of Berlin, 12203
About this study
Official title: Diagnostic Accuracy of Magnetocardiography in Inflammatory Cardiomyopathies: A Comparison With Noninvasive Cardiovascular Magnetic Resonance (CMR) and Invasive Endomyocardial Biopsy
Accurate and rapid screening is an unmet medical need to address the increasing demand for advanced diagnostic workup in patients with suspected cardiomyopathy. Due to an overwhelmed health care system, advanced imaging is not always immediately available leading to underdiagnosis and progression of cardiomyopathies to advanced stages and sudden death. The investigator's recently demonstrated in a retrospective study that magnetocardiography (MCG) could be a suitable tool to detect inflammatory and other types of cardiomyopathies in a highly effective manner and without any safety issues. In this study, the investigator's test diagnostic accuracy of MCG prospectively.
Read the detailed description
Inflammatory cardiomyopathy is one of the most common causes of sudden cardiac death in young adults, as it frequently remains undetected. Also, it is a common cause of heart failure, which may lead to circulatory collapse, requiring mechanical circulatory support or heart transplant. Some patients may require immunosuppression in addition to standard heart failure therapy. Early initiation of therapy is crucial for optimal outcomes.
Inflammatory disease of the heart muscle/inflammatory cardiomyopathy can be challenging to diagnose because it often requires expensive, time intense, and sometimes invasive testing, such as cardiac magnetic resonance imaging (MRI) and endomyocardial biopsies (EMB). As a result, there is an unmet clinical need for low threshold diagnostic screening in patients with suspected cardiomyopathy.
In this study the investigator's evaluate the diagnostic accuracy of magnetocardiography (MCG) in detecting inflammatory and other types of cardiomyopathy. Diagnostic accuracy will be compared to results from advanced imaging (cardiac magnetic resonance (CMR) imaging and/or positron emission computed tomography (PET-CT)) and where available to histology from endomyocardial biopsy/EMB.
CMR provides comprehensive structural and functional data while detecting consequences of inflammation, such as edema and late gadolinium enhancement. PET-CT detects the level of activity and the extent of inflammation through measurement of glucose metabolism. However, it cannot be applied frequently because of the associated radiation exposure. EMB is the gold standard for definitive diagnosis of inflammatory cardiomyopathy and is crucial for initiation of immunosuppressive therapy, as active viral infection should be excluded. However, the limited diagnostic yield due to sampling error and risk of potential complications limit its use to selected cases where there is a high suspicion that specific treatment may be necessary.
MCG is based on detecting the movement of ions in the myocardium. When an action potential in the heart is generated, it creates voltage changes and consequently an electromagnetic field. The strength and direction of this field are affected by the flow of ions both inside and outside the cells. Typically, the magnetic field produced by the heart ranges from from 10-15 to 11-11 Tesla.
MCG uses a superconducting quantum interference device (SQUID) to detect the electromagnetic field of the heart (up to 10*-15 Tesla). Measurements take place during the ascending T wave of the cardiac cycle. A vector score > 0.051 was determined to be pathologic in our recently published retrospective study. The investigator's will assesss diagnostic accuracy of MCG relative to cardiac magnetic resonance imaging (CMR) or positron emission computed tomography (PET-CT) and endomyocardial biopsy (EMB). Results from EMB take precedence over advanced imaging. Results from MCG will be independently assessed by two trained professionals blinded to the clinical diagnosis, with a third expert to adjudicate in cases of disagreement.
The MCG system utilizes an array of 64 highly sensitive magnetic sensors known as superconducting quantum interference devices (SQUIDs). These sensors are placed in a shielded environment to reduce interference from external electromagnetic sources. SQUIDs capture variations in the heart's magnetic field throughout the cardiac cycle and correlate these changes with the ECG. To filter out electromagnetic noise, several frequency filters are applied. The measurements provide a three-dimensional view of the magnetic field, which is used to generate a composite vector representing the primary electrical axis of the heart. In assessing inflammatory cardiomyopathies, the focus is on the vector associated with the T-wave of the action potential, specifically between the beginning of the T-wave on a 12-lead ECG to the maximum of the T-wave (T-beg-Tmax interval). A T-wave/MCG vector T-beg-Tmax value ≥ 0.051 has been identified as indicative of pathology, as demonstrated in our previous research (Brala et al, JAHA, 2023, PMID: 36744683).
The goal of this project is to validate the diagnostic accuracy of MCG for diagnosing inflammatory and other types of cardiomyopathy.
- Conditions
- Cardiomyopathies
- Being tested
- Magnetocardiography scan
- Keywords
- Magnetocardiography, Myocarditis, Inflammatory Cardiomyopathy, Cardiomyopathy, Biomarker, Heart Failure, Invasive diagnostic procedure, Noninvasive, endomyocardial biopsy, cardiac magnetic resonance imaging
- Medical subject headings
- Cardiomyopathies, Myocarditis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetocardiography scanDiagnostic test
The MCG system utilizes an array of 64 highly sensitive magnetic sensors known as superconducting quantum interference devices (SQUIDs). These sensors are placed in a shielded environment to reduce interference from external electromagnetic sources. SQUIDs capture variations in the heart's magnetic field throughout the cardiac cycle and correlate these changes with the QRS complex. To filter out electromagnetic noise, several frequency filters are applied. The measurements provide a three-dimensional view of the magnetic field, which is used to generate a composite vector representing the primary electrical axis of the heart. In assessing inflammatory cardiomyopathies, the focus is on the vector associated with the T-wave of the action potential, i.e. the vector from the T-wave beginning to the maximum (T-beg-Tmax interval). A T-wave/MCG vector T-beg-Tmax value ≥ 0.051 has been identified as indicative of pathology, as demonstrated in our previous research.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected inflammatory cardiomyopathy | Adult patients experiencing cardiac symptoms such as chest pain or pressure, dyspnea on exertion, and heart racing are included after rule out of obstructive coronary artery disease by coronary angiography (ANOCA). Patients have to be stable enough to undergo advanced imaging and magnetocardiography measurements. Patients on immunosuppressive therapy and/or with intracardiac metal devices are excluded.
110 patients for this group are planned. Receives: Diagnostic Test: Magnetocardiography scan | |
| Cardiac Healthy Controls | Healthy individuals with no history of cardiac disease and unremarkable physical exam, 12-lead ECG, and echocardiography. 220 patients for this group are planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate diagnosis of inflammatory cardiomyopathy
The main outcome is the correct diagnosis of an inflammatory cardiomyopathy, the noninvasive gold standard cardiac magnetic resonance imaging or invasive gold standard endomyocardial biopsy.
Measured: MCG is obtained at the time of clinical presentation. Accuracy of diagnosis by MCG is tested with the current diagnostic gold standard methods: CMR, PET-CT and/or EMB, when clinically indicated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start14 Dec 2022
- Primary completion13 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathiesStudies 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
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Berlin Institute of Health at Charité, Charite University, Berlin, Germany, Biomagnetik Park Holding GmbH
- Responsible party
- Principal investigator, Bettina Heidecker, German Heart Institute
- Investigators
- Bettina Heidecker, MD, Principal investigator, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689098
- Sponsor's protocol ID
- Magma-Study
- Acronym
- MagMa
- Status last verified
- Dec 2024
- First submitted
- 23 Oct 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the study can be made available upon request from the principal investigator PD Dr. med. Bettina Heidecker in a de-identified form. A data use agreement must be signed before access to data. Access is only granted to academic staff.
Publications
Suwalski P, Wilke F, Latinova E, Paci G, Satilmis G, Klingel K, Kelle S, Weiner J 3rd, Beule D, Luscher TF, Landmesser U, Heidecker B. The MagMa Study: Quantum Magnetocardiography in Cardiomyopathy. JACC Heart Fail. 2026 Aug;14(8):103182. doi: 10.1016/j.jchf.2026.103182.
PubMed 42547165
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Magnetocardiography in Inflammatory Cardiomyopathies: A Comparison With Noninvasive Cardiovascular Magnetic Resonance (CMR) and Invasive Endomyocardial Biopsy
- ClinicalTrials.gov ID
- NCT06689098
- Acronym / sponsor ID
- MagMa / Magma-Study
- Conditions
- Cardiomyopathies
- Keywords
- Magnetocardiography, Myocarditis, Inflammatory Cardiomyopathy, Cardiomyopathy, Biomarker, Heart Failure, Invasive diagnostic procedure, Noninvasive, endomyocardial biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Berlin Institute of Health at Charité, Charite University, Berlin, Germany, Biomagnetik Park Holding GmbH
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Nov 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.
Accurate and rapid screening is an unmet medical need to address the increasing demand for advanced diagnostic workup in patients with suspected cardiomyopathy. Due to an overwhelmed health care system, advanced imaging is not always immediately available leading to underdiagnosis and progression of cardiomyopathies to advanced stages and sudden death. The investigator's recently demonstrated in a retrospective study that magnetocardiography (MCG) could be a suitable tool to detect inflammatory and other types of cardiomyopathies in a highly effective manner and without any safety issues. In this study, the investigator's test diagnostic accuracy of MCG prospectively.
Detailed description
Inflammatory cardiomyopathy is one of the most common causes of sudden cardiac death in young adults, as it frequently remains undetected. Also, it is a common cause of heart failure, which may lead to circulatory collapse, requiring mechanical circulatory support or heart transplant. Some patients may require immunosuppression in addition to standard heart failure therapy. Early initiation of therapy is crucial for optimal outcomes.
Inflammatory disease of the heart muscle/inflammatory cardiomyopathy can be challenging to diagnose because it often requires expensive, time intense, and sometimes invasive testing, such as cardiac magnetic resonance imaging (MRI) and endomyocardial biopsies (EMB). As a result, there is an unmet clinical need for low threshold diagnostic screening in patients with suspected cardiomyopathy.
In this study the investigator's evaluate the diagnostic accuracy of magnetocardiography (MCG) in detecting inflammatory and other types of cardiomyopathy. Diagnostic accuracy will be compared to results from advanced imaging (cardiac magnetic resonance (CMR) imaging and/or positron emission computed tomography (PET-CT)) and where available to histology from endomyocardial biopsy/EMB.
CMR provides comprehensive structural and functional data while detecting consequences of inflammation, such as edema and late gadolinium enhancement. PET-CT detects the level of activity and the extent of inflammation through measurement of glucose metabolism. However, it cannot be applied frequently because of the associated radiation exposure. EMB is the gold standard for definitive diagnosis of inflammatory cardiomyopathy and is crucial for initiation of immunosuppressive therapy, as active viral infection should be excluded. However, the limited diagnostic yield due to sampling error and risk of potential complications limit its use to selected cases where there is a high suspicion that specific treatment may be necessary.
MCG is based on detecting the movement of ions in the myocardium. When an action potential in the heart is generated, it creates voltage changes and consequently an electromagnetic field. The strength and direction of this field are affected by the flow of ions both inside and outside the cells. Typically, the magnetic field produced by the heart ranges from from 10-15 to 11-11 Tesla.
MCG uses a superconducting quantum interference device (SQUID) to detect the electromagnetic field of the heart (up to 10*-15 Tesla). Measurements take place during the ascending T wave of the cardiac cycle. A vector score > 0.051 was determined to be pathologic in our recently published retrospective study. The investigator's will assesss diagnostic accuracy of MCG relative to cardiac magnetic resonance imaging (CMR) or positron emission computed tomography (PET-CT) and endomyocardial biopsy (EMB). Results from EMB take precedence over advanced imaging. Results from MCG will be independently assessed by two trained professionals blinded to the clinical diagnosis, with a third expert to adjudicate in cases of disagreement.
The MCG system utilizes an array of 64 highly sensitive magnetic sensors known as superconducting quantum interference devices (SQUIDs). These sensors are placed in a shielded environment to reduce interference from external electromagnetic sources. SQUIDs capture variations in the heart's magnetic field throughout the cardiac cycle and correlate these changes with the ECG. To filter out electromagnetic noise, several frequency filters are applied. The measurements provide a three-dimensional view of the magnetic field, which is used to generate a composite vector representing the primary electrical axis of the heart. In assessing inflammatory cardiomyopathies, the focus is on the vector associated with the T-wave of the action potential, specifically between the beginning of the T-wave on a 12-lead ECG to the maximum of the T-wave (T-beg-Tmax interval). A T-wave/MCG vector T-beg-Tmax value ≥ 0.051 has been identified as indicative of pathology, as demonstrated in our previous research (Brala et al, JAHA, 2023, PMID: 36744683).
The goal of this project is to validate the diagnostic accuracy of MCG for diagnosing inflammatory and other types of cardiomyopathy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected inflammatory cardiomyopathy | – | Diagnostic Test: Magnetocardiography scanAdult patients experiencing cardiac symptoms such as chest pain or pressure, dyspnea on exertion, and heart racing are included after rule out of obstructive coronary artery disease by coronary angiography (ANOCA). Patients have to be stable enough to undergo advanced imaging and magnetocardiography measurements. Patients on immunosuppressive therapy and/or with intracardiac metal devices are excluded. 110 patients for this group are planned. |
| Cardiac Healthy Controls | – | –Healthy individuals with no history of cardiac disease and unremarkable physical exam, 12-lead ECG, and echocardiography. 220 patients for this group are planned |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The healthy controls do not have any history of cardiac disease. Standard examiniations ensure that there are no undiagnosed conditions.
Key inclusion criteria (1 listed)
- Patients with angina-like symptoms after exclusion of coronary artery disease
Key exclusion criteria (1 listed)
- Presence of intracardiac metal devices and prior treatment with immunosuppressants
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 |
|---|---|---|
| Magnetocardiography scanThe MCG system utilizes an array of 64 highly sensitive magnetic sensors known as superconducting quantum interference devices (SQUIDs). These sensors are placed in a shielded environment to reduce interference from external electromagnetic sources. SQUIDs capture variations in the heart's magnetic field throughout the cardiac cycle and correlate these changes with the QRS complex. To filter out electromagnetic noise, several frequency filters are applied. The measurements provide a three-dimensional view of the magnetic field, which is used to generate a composite vector representing the primary electrical axis of the heart. In assessing inflammatory cardiomyopathies, the focus is on the vector associated with the T-wave of the action potential, i.e. the vector from the T-wave beginning to the maximum (T-beg-Tmax interval). A T-wave/MCG vector T-beg-Tmax value ≥ 0.051 has been identified as indicative of pathology, as demonstrated in our previous research. | Diagnostic test | Patients with suspected inflammatory cardiomyopathy |
Primary outcome
Accurate diagnosis of inflammatory cardiomyopathy
Time frame: MCG is obtained at the time of clinical presentation. Accuracy of diagnosis by MCG is tested with the current diagnostic gold standard methods: CMR, PET-CT and/or EMB, when clinically indicated.
The main outcome is the correct diagnosis of an inflammatory cardiomyopathy, the noninvasive gold standard cardiac magnetic resonance imaging or invasive gold standard endomyocardial biopsy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 42547165Suwalski P, Wilke F, Latinova E, Paci G, Satilmis G, Klingel K, Kelle S, Weiner J 3rd, Beule D, Luscher TF, Landmesser U, Heidecker B. The MagMa Study: Quantum Magnetocardiography in Cardiomyopathy. JACC Heart Fail. 2026 Aug;14(8):103182. doi: 10.1016/j.jchf.2026.103182.
- Individual participant dataSharing planned: Yes. Data from the study can be made available upon request from the principal investigator PD Dr. med. Bettina Heidecker in a de-identified form. A data use agreement must be signed before access to data. Access is only granted to academic staff.
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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.
Bettina Heidecker, MD principal investigator
Deutsches Herzzentrum der Charité
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 Cardiomyopathies, run by German Heart Institute 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accurate diagnosis of inflammatory cardiomyopathy (time frame: MCG is obtained at the time of clinical presentation. Accuracy of diagnosis by MCG is tested with the current diagnostic gold standard methods: CMR, PET-CT and/or EMB, when clinically indicated.). 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 NCT06689098, which also lists 1 linked publication.
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 19 Dec 2024.