Evaluating endomyocardial biopsy and tailored treatments for inflammatory heart disease
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
This study is trying to see if a heart tissue test and personalized treatments can help people with inflammatory heart disease, especially those with myocarditis and heart rhythm issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT04521790 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of endomyocardial biopsy (EMB) and aetiology-based treatments in patients with inflammatory heart disease, particularly focusing on myocarditis and its arrhythmic manifestations. It includes both retrospective and prospective phases, analyzing clinical data before and after myocarditis diagnosis. The study aims to compare EMB with noninvasive diagnostic techniques, assess blood biomarkers for various clinical aspects, and evaluate the healing process in different patient subgroups. By integrating multiple diagnostic and therapeutic strategies, the study seeks to optimize management for patients with myocarditis.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have clinically suspected myocarditis.
Not a fit: Patients under 18 years of age or those who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with inflammatory heart disease, potentially reducing morbidity and mortality.
How similar studies have performed: While the approach of using EMB in myocarditis is established, the integration of multiple diagnostic modalities and aetiology-based treatments in a multicenter setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent. * Age ≥ 18 years. * Clinically suspected myocarditis. * Enrollment performed by one of the participating Centers. Exclusion Criteria: * Absence of written informed consent. * Age \< 18 years (paediatric population).
Where this trial is running
Milan, Milano
- IRCCS San Raffaele Scientific Institute — Milan, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Peretto, MD
- Email: peretto.giovanni@hsr.it
- Phone: +39 0226437482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.