Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry.
Enrico Ammirati, Manlio Cipriani, Claudio Moro...
https://pubmed.ncbi.nlm.nih.gov/29764898Actively Recruiting
Age: 18Years +
All Genders
ID04521790
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
Led by Scientific Institute San Raffaele · Updated on 2024-09-19
1000
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent.
- Age 18 years or older.
- Clinically suspected myocarditis.
- Enrollment performed by one of the participating Centers.
You will not qualify if you...
- Absence of written informed consent.
- Age younger than 18 years (pediatric population).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Diagnostic Evaluation
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
Treatment
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
Follow-up
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
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Scientific Institute
Milan, Milano, Italy, 20132
Actively Recruiting
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Research Team
G
Giovanni Peretto, MD
S
Simone Sala, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Unexpected acute lymphocytic virus-negative myocarditis in a patient with limited cutaneous systemic sclerosis: a case report.
G De Luca, C Campochiaro, S Franchini...
https://pubmed.ncbi.nlm.nih.gov/30269630Arrhythmias in myocarditis: State of the art.
Giovanni Peretto, Simone Sala, Stefania Rizzo...
https://pubmed.ncbi.nlm.nih.gov/30476544Impact of systemic immune-mediated diseases on clinical features and prognosis of patients with biopsy-proved myocarditis.
Giovanni Peretto, Simone Sala, Giacomo De Luca...
https://pubmed.ncbi.nlm.nih.gov/30522885Successful use of sirolimus in a patient with cardiac microangiopathy in primary antiphospholipid syndrome.
S Sartorelli, G De Luca, C Campochiaro...
https://pubmed.ncbi.nlm.nih.gov/30794015Two-dimensional and three-dimensional cardiac magnetic resonance feature-tracking myocardial strain analysis in acute myocarditis patients with preserved ejection fraction.
Marco Gatti, Anna Palmisano, Riccardo Faletti...
https://pubmed.ncbi.nlm.nih.gov/30929101Efficacy and safety of mycophenolate mofetil in patients with virus-negative lymphocytic myocarditis: A prospective cohort study.
Giacomo De Luca, Corrado Campochiaro, Silvia Sartorelli...
https://pubmed.ncbi.nlm.nih.gov/31488318Thyroid dysfunction in adult patients with biopsy-proved myocarditis: Screening and characterization.
Giovanni Peretto, Cristina Basso, Paolo Della Bella...
https://pubmed.ncbi.nlm.nih.gov/31733987Tocilizumab for the Treatment of Myocardial Inflammation Shown by Cardiac Magnetic Resonance: Report of Two Cases and Rationale for Its Therapeutic Use.
Corrado Campochiaro, Giacomo De Luca, Alessandro Tomelleri...
https://pubmed.ncbi.nlm.nih.gov/31790000Systemic sclerosis myocarditis has unique clinical, histological and prognostic features: a comparative histological analysis.
Giacomo De Luca, Corrado Campochiaro, Maria De Santis...
https://pubmed.ncbi.nlm.nih.gov/31990340