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ID04521790

Study on Diagnostic and Treatment Approaches for Inflammatory Heart Disease With and Without Arrhythmias Including Endomyocardial Biopsy and Tailored Therapies

Led by Scientific Institute San Raffaele · Updated on 2024-09-19

1000

Participants Needed

1

Research Sites

521 weeks

Total Duration

AI-Summary

What this Trial Is About

Myocarditis is a complex inflammatory heart condition that can arise from viral infections, autoimmune responses, or toxic agents. It presents with symptoms such as chest pain, heart failure, and various arrhythmias. The course of the disease varies widely, from mild and self-limiting to severe forms leading to chronic cardiomyopathy or rapid deterioration. This observational study, now multicenter and both retrospective and prospective, seeks to clarify many aspects of myocarditis, especially its arrhythmic manifestations, diagnostic approaches, and treatment strategies. The study compares invasive and noninvasive diagnostic techniques, including endomyocardial biopsy EMB, cardiac magnetic resonance CMR, delayed-enhanced CT DECT, and PET scans, to better define myocarditis diagnosis and staging. Participants are grouped into arrhythmic and non-arrhythmic categories, with further subgroups based on arrhythmia types or clinical presentations. Treatment is personalized, integrating international guidelines and specialized center experience, involving support treatments, cardiac medical therapy, aetiology-specific treatment, device implants, and arrhythmia ablation where appropriate. Participants undergo thorough diagnostic workups including blood tests, ECG, echocardiograms, coronary imaging, and continuous monitoring. Those with arrhythmias receive additional tailored management. Follow-up includes repeated imaging and biomarker assessments to track disease progression, healing timing, and response to treatments over up to 10 years. The study measures outcomes such as major cardiac events over multiple follow-up periods and diagnostic accuracy of different methods, aiming to improve myocarditis diagnosis, treatment, and prognosis.

CONDITIONS

Brief Title

Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management

Research Team

G

Giovanni Peretto, MD

S

Simone Sala, MD

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