Using Heart Imaging to Predict Dangerous Heart Rhythms in Patients After Myocarditis An International Case-Control Study
Led by Centro Medico Teknon · Updated on 2024-12-12
150
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Ventricular arrhythmias are often linked to structural heart diseases such as myocardial infarction, myocarditis, and non-ischemic cardiomyopathies. This research explores the role of scar tissue in the heart, particularly in patients who have had myocarditis, using advanced cardiac magnetic resonance imaging to analyze scar patterns and predict arrhythmia risk. The study aims to improve risk assessment beyond the current standard based on left ventricular ejection fraction, focusing on patients without previous arrhythmia signs.
The study is observational and compares patients who experience sudden cardiac death or sustained ventricular arrhythmias to those who do not, analyzing heart scar characteristics through imaging data. Researchers will evaluate scar mass, border zone channels, and other tissue features obtained from cardiac MRI performed at least six months after myocarditis diagnosis. The goal is to better predict arrhythmia risk and refine implantable cardioverter-defibrillator ICD therapy recommendations.
Participants will undergo cardiac magnetic resonance imaging and clinical follow-up for up to two years to monitor for arrhythmic events or sudden cardiac death. Researchers will collect data on heart function and scar tissue features, including advanced imaging markers. Outcomes include the incidence of sudden cardiac death, sustained ventricular tachycardia, and appropriate ICD therapies. Safety, consent, and feasibility will be ensured throughout the study period ending in December 2026.
CONDITIONS
Brief Title
Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-control Study
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Unable or contraindicated to undergo late gadolinium enhancement cardiac magnetic resonance imaging
Receiving other investigational treatments
Medical, geographical, or social factors making participation impractical
Inability to provide written informed consent or refusal to participate
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Occurs once after screening
Participants undergo cardiac magnetic resonance imaging (CMR) and other diagnostic tests to assess scar mass, BZC mass, and other cardiac features related to myocarditis.
1 imaging visit
Long-term Monitoring
Duration - Up to 2 years
Participants are observed for up to 2 years to record the occurrence of sudden cardiac death, sustained ventricular arrhythmias, or defibrillator therapy.
Follow-up visits as needed for monitoring
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Scar Characterization to Predict Life-Threatening Arrhythmic Events and Sudden Cardiac Death in Patients With Cardiac Resynchronization Therapy: The GAUDI-CRT Study.
Juan Acosta, Juan Fernández-Armenta, Roger Borràs...