Magnetocardiography as a Diagnostic Screening Tool for Myocarditis and Other Types of Cardiomyopathy
NCT ID: NCT06689098
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
330 participants
OBSERVATIONAL
2022-12-14
2024-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Magnetocardiography scan
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.
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
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnetocardiography scan
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Berlin Institute of Health at Charité
UNKNOWN
Charite University, Berlin, Germany
OTHER
Biomagnetik Park Holding GmbH
UNKNOWN
German Heart Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bettina Heidecker
Head of Heart Failure and Cardiomyopathy
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bettina Heidecker, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum der Charité
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Deutsches Herzzentrum der Charité
Steglitz, State of Berlin, Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Magma-Study
Identifier Type: -
Identifier Source: org_study_id