Reply: Genetic Basis for Acute Myocarditis Presenting With Ventricular Arrhythmias?
Giovanni Peretto, Simone Sala, Paolo Della Bella...
https://pubmed.ncbi.nlm.nih.gov/32616153/Actively Recruiting
Led by Scientific Institute San Raffaele · Updated on 2024-09-19
1000
Participants Needed
1
Research Sites
521 weeks
Total Duration
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
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
G
Giovanni Peretto, MD
S
Simone Sala, MD
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Scientific Institute San Raffaele
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Varies depending on clinical presentation
Participants undergo a personalized diagnostic workup including blood exams, ECG, continuous monitoring, echocardiogram, coronary imaging, advanced imaging techniques and, when clinically indicated, endomyocardial biopsy to confirm myocarditis and determine its aetiology.
1 to 2 visits depending on clinical needs
Duration - Duration varies according to individual treatment plans
Participants receive patient-tailored treatments based on myocarditis aetiology and clinical presentation, including cardiac medical treatment, support treatments, device implants, antiarrhythmic drugs, arrhythmia ablation, and aetiology-specific therapies.
Visits scheduled as needed per treatment and follow-up requirements
Duration - Up to 10 years
Participants are monitored with regular assessments including imaging, biomarkers, arrhythmia surveillance, and clinical evaluations to track myocarditis healing, arrhythmia management, and treatment response over up to 10 years.
Regular visits including imaging and biomarker assessments, arrhythmia monitoring, and clinical evaluations throughout follow-up
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/32154772/Scientific Institute San Raffaele
Lead Sponsor