Registry for patients with non-ischemic cardiomyopathies
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
This study is collecting information from people with non-ischemic cardiomyopathies to see how to better diagnose and manage their condition and predict potential heart rhythm problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06607471 on ClinicalTrials.gov |
What this trial studies
This study collects clinical data from both retrospective and prospective patients suspected or diagnosed with non-ischemic cardiomyopathies (NICM). It aims to improve diagnostic methods, identify disease-specific signatures, and develop risk prediction models for arrhythmic events. The registry will utilize various diagnostic techniques, including genetic testing, cardiac magnetic resonance, and other imaging modalities to enhance understanding and management of NICM. By analyzing a diverse patient population, the study seeks to address unresolved questions in the field of arrhythmogenic-inflammatory NICM.
Who should consider this trial
Good fit: Ideal candidates include individuals with clinical suspicion or proven diagnosis of any form of non-ischemic cardiomyopathy.
Not a fit: Patients with proven diagnoses of cardiac diseases other than non-ischemic cardiomyopathy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and personalized treatment strategies for patients with non-ischemic cardiomyopathies.
How similar studies have performed: While similar approaches have been explored, this registry aims to provide a comprehensive and novel perspective on non-ischemic cardiomyopathies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent. For pediatric patients, consent will be obtained by parents, according to the laws applicable in each of the participating countries. * Clinical suspicion of NICM, and/or proven diagnosis of any NICM and/or genotype consistent with any NICM. NICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic/autoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge. Exclusion Criteria: * Absent informed consent. * Proven diagnosis of cardiac disease alternative to NICM. * Lack of diagnostic workup suitable for diagnosing NICM, detecting arrhythmias, or detecting M-Infl. * For patients retrospectively enrolled: lack of active status of follow-up at the enrolling center.
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.