RECRUITINGOBSERVATIONAL
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. LVEF \<50% and/or
2. 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)
Who Should NOT Join This Trial:
- A significant other cause of decreased LVEF such as:
1. 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
2. Significant congenital heart disease requiring intervention
3. Primary valvular disease including moderate to severe aortic stenosis and moderate to severe mitral stenosis, primary severe mitral regurgitation (secondary valvular disease such as mitral regurgitation/tricuspid regurgitation are not exclusion criteria)
4. Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
5. Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
6. Clear history of burned out hypertrophic cardiomyopathy
7. Already had a transplantation at time of first CMR
8. Refusal to provide willing to sign a consent form
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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. LVEF \<50% and/or
2. 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 Criteria:
* A significant other cause of decreased LVEF such as:
1. 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
2. Significant congenital heart disease requiring intervention
3. Primary valvular disease including moderate to severe aortic stenosis and moderate to severe mitral stenosis, primary severe mitral regurgitation (secondary valvular disease such as mitral regurgitation/tricuspid regurgitation are not exclusion criteria)
4. Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
5. Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
6. Clear history of burned out hypertrophic cardiomyopathy
7. Already had a transplantation at time of first CMR
8. 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.
Locations (1)
Montreal Heart Institute
Montreal, Quebec, Canada