Randomized study on the efficacy of immunosuppressive therapy in patients with virus-negative inflammatory cardiomyopathy: the TIMIC study.
Andrea Frustaci, Matteo A Russo, Cristina Chimenti
https://pubmed.ncbi.nlm.nih.gov/19556262Actively Recruiting
Led by Scientific Institute San Raffaele · Updated on 2024-09-19
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
This research focuses on myocarditis, an inflammatory heart disease often caused by viral infections, autoimmune reactions, or toxic agents. Myocarditis can present with a variety of symptoms including chest pain, heart failure, and various irregular heart rhythms. The condition's outcome can range from mild and self-limiting to severe forms leading to chronic heart problems or sudden adverse events. The study aims to enhance understanding and management of myocarditis, especially its arrhythmic forms, by comparing diagnostic and therapeutic strategies across different patient groups. The study is observational, both retrospective and prospective, and involves multiple centers. It compares invasive endomyocardial biopsy with noninvasive imaging techniques such as cardiac magnetic resonance, CT scans, and PET scans. Patients receive diagnostic and treatment plans tailored to their condition, including support treatments, cardiac medications, device implants, and arrhythmia ablation when needed. Patients with arrhythmias are categorized into groups based on the type and severity of their arrhythmia, and specific management plans are applied accordingly. Participants provide data through clinical assessments including blood tests, electrocardiograms, imaging, and continuous heart monitoring. The study tracks major and minor cardiac events, diagnostic accuracy, biomarker levels, arrhythmia characteristics, and treatment responses over time, with follow-ups extending up to 10 years. Monitoring includes reassessment for disease progression or healing and evaluation of arrhythmia interventions. The goal is to develop optimal diagnostic and therapeutic approaches for pediatric patients with myocarditis and related arrhythmias.
CONDITIONS
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Baseline assessment period
Participants undergo diagnostic workup including blood exams, ECG, continuous monitoring, echocardiogram, coronary artery imaging, and advanced imaging techniques such as CMR, DECT, or PET scan. Endomyocardial biopsy (EMB) will be performed when clinically indicated.
1 to 2 visits depending on diagnostic procedures
Duration - Variable duration depending on clinical need and treatment response
Participants receive patient-tailored support treatment, cardiac medical treatment, aetiology-specific treatment, device implants, or arrhythmia ablation based on clinical indications and group assignment (arrhythmic or nonarrhythmic).
Visits as clinically indicated for treatment and monitoring
Duration - Up to 10 years
Participants undergo intensive or standard follow-up monitoring with repeat imaging, blood exams, arrhythmia monitoring, and clinical assessments to evaluate myocarditis healing, treatment response, and arrhythmic events over time.
Multiple visits and assessments throughout follow-up period
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Milano, Italy, 20132
Actively Recruiting
G
Giovanni Peretto, MD
S
Simone Sala, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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