Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository
Improving Risk Prediction in Non-ischemic Cardiomyopathy (NICM): An Individualized Multimodality Approach Registry, Biobank and Imaging Data Repository
Montreal Heart Institute
2,000 participants
Apr 2, 2024
OBSERVATIONAL
Conditions
Summary
The main goal of CaNICM is to create a central database that includes a biobank and an imaging data repository for patients with non-ischemic cardiomyopathy (NICM), as well as for at-risk family members. This includes people who carry rare genetic variants linked to NICM but do not show symptoms, and first-degree relatives. The specific goals of this database and biobank are to: Enhance investigators' ability to predict the risk of heart rhythm disorders in patients with NICM. Optimize the timing and approach for screening family members who may carry the disease - determining who to test, when, and how. Find the best ways to treat family members early to prevent or slow the disease. Future Phase - Phase 2 Goal: 4\. Prospectively evaluate how well this risk prediction model works in real-life clinical settings, and compare it to the current approach, which is often based on a single risk factor.
Eligibility
Inclusion Criteria2
- LVEF <50% and/or
- LVEF 50-55% with presence of clinically significant late gadolinium enhancement or LV dilatation and being carrier of a non ischemic cardiomyopathy causing gene (Pathogenic or likely pathogenic variant in a Clingen moderate or definite gene)
Exclusion Criteria13
- A significant other cause of decreased LVEF such as:
- Coronary artery stenosis (Significant lesion on proximal Left anterior descending or Left main, or ≥2 main branches with stenosis. Significant lesion is defined as >70% of any artery or >50% for the left main artery) or prior history of type 1 myocardial infarction
- Significant congenital heart disease requiring intervention
- Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
- Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
- Clear history of burned out hypertrophic cardiomyopathy
- Already had a transplantation at time of first CMR
- Refusal to provide informed consent
- Additional remarks:
- Patients aged > 70 years of age at first contact with a cardiologist regarding the cardiomyopathy will be limited to maximum 10% of the total enrolled patients by center.
- Patients with risk factors (for example, chemotherapy, radiotherapy, alcohol…) for cardiomyopathy are not excluded unless they are deemed to completely account for the phenotype per the treating physician.
- The inclusion is not restricted to adult patients and is planned to be extended to the pediatric population.
- All included patients are recommended to have a CMR performed within 3 years of inclusion.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07110818