Magnetocardiography as a Diagnostic Screening Tool for Myocarditis and Other Types of Cardiomyopathy

NCT06689098 | Completed

• 1 other identifier: Magma-Study
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiomyopathies

Keywords

Magnetocardiography; Myocarditis; Inflammatory Cardiomyopathy; Cardiomyopathy; Biomarker; Heart Failure; Invasive diagnostic procedure; Noninvasive, endomyocardial biopsy; cardiac magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

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.

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

Interventions

Magnetocardiography scan DIAGNOSTIC_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.

Patients with suspected inflammatory cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The healthy controls do not have any history of cardiac disease. Standard examiniations ensure that there are no undiagnosed conditions.

You may not qualify if:

• Presence of intracardiac metal devices and prior treatment with immunosuppressants

Sponsors & Collaborators

• German Heart Institute: lead
• Berlin Institute of Health at Charité: collaborator
• Charite University, Berlin, Germany: collaborator
• Biomagnetik Park Holding GmbH: collaborator

Study Sites (1)

Deutsches Herzzentrum der Charité

Steglitz, State of Berlin, 12203, Germany

Location

MeSH Terms

Conditions

Cardiomyopathies; Myocarditis; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bettina Heidecker, MD

  Deutsches Herzzentrum der Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Heart Failure and Cardiomyopathy

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 14, 2024
• Study Start: December 14, 2022
• Primary Completion: November 13, 2024
• Study Completion: December 1, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: see above
• Access Criteria: see above

Locations

DE (1)