'Hot phase' clinical presentation in arrhythmogenic cardiomyopathy.
Riccardo Bariani, Alberto Cipriani, Stefania Rizzo...
https://pubmed.ncbi.nlm.nih.gov/33313835Actively Recruiting
Age: 18Years +
All Genders
ID06607471
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.
Led by Scientific Institute San Raffaele · Updated on 2024-09-23
15000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a diverse group of heart muscle diseases known as non-ischemic cardiomyopathies (NICM), which do not involve blocked coronary vessels but cause changes in the heart muscle's structure and function. These include common types like dilated, hypertrophic, restrictive, and arrhythmogenic cardiomyopathies, as well as less common forms and overlapping or undefined types. The study focuses on two main patterns found in NICM: arrhythmic issues, including dangerous heart rhythms, and inflammation of the heart muscle, both of which affect diagnosis, prognosis, and treatment options. The study collects data from past and current patients with suspected or confirmed NICM through a registry. Participants are divided into groups based on their clinical presentation: those with arrhythmic symptoms and those without. Diagnostic methods include genetic tests, cardiac imaging (such as MRI, CT scan, PET), biopsies, and electrophysiological tests to assess arrhythmias and inflammation. Treatments studied are tailored to each patient and may include medical therapies, implantable devices, immunosuppressive drugs, and procedures like catheter ablation, all evaluated by a multidisciplinary team. Participants' clinical data and diagnostic results are gathered and analyzed over time to improve understanding of NICM. The study measures diagnostic accuracy of various tests at multiple time points up to 30 years. Researchers also look at the prevalence of inflammation and arrhythmias, correlations with genetic and imaging findings, risk prediction models, and treatment effects on heart events. This comprehensive approach aims to enhance diagnosis, risk assessment, and personalized treatment strategies for NICM patients.
CONDITIONS
Brief Title
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.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained from the participant or, for pediatric patients, from their parents according to local laws.
- Clinical suspicion or confirmed diagnosis of any form of non-ischemic cardiomyopathy (NICM) or genotype consistent with NICM.
- NICM types include but are not limited to dilated, hypertrophic, restrictive, arrhythmogenic, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic/autoimmune cardiomyopathies, channelopathies with structural changes, left ventricular noncompaction, peripartum cardiomyopathy, arrhythmogenic mitral valve prolapse, Anderson-Fabry disease, athlete's heart, undefined and overlapping cardiomyopathies.
- Additional NICM diseases may be included as knowledge advances.
You will not qualify if you...
- Lack of informed consent.
- Confirmed diagnosis of a cardiac disease other than non-ischemic cardiomyopathy.
- Insufficient diagnostic workup to diagnose NICM, detect arrhythmias, or detect myocardial inflammation.
- For retrospective patients, no active follow-up status at the enrolling center.
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 visit (in-person)
Monitoring
Duration - Up to 30 years
Participants with non-ischemic cardiomyopathies are observed in a registry to collect clinical data and to assess diagnostic, prognostic, and therapeutic outcomes over time.
Follow-up assessments at baseline and multiple timepoints up to 30 years
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
4
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C Basso, G Thiene, D Corrado...
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