Registry and biobank of non-ischemic cardiomyopathy with linked heart imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CaNICM is an observational registry that will assemble a centralized clinical database, biobank, and imaging repository for patients with non-ischemic cardiomyopathy and their first-degree or genetic at-risk relatives. Enrollment includes clinical data extraction, questionnaires, cardiac magnetic resonance imaging (CMR), transthoracic echocardiography (TTE), ECGs in XML format, and blood sampling for biobanking, with data coded and stored in a REDCap-based eCRF. Genetic carrier status (pathogenic or likely pathogenic variants in ClinGen-moderate/definite genes) and imaging markers such as late gadolinium enhancement will be captured to support risk model development. A planned future phase will prospectively test the developed risk prediction model in routine clinical settings and compare it to current single-factor approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Montreal Heart Institute
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Melissa Lavallée
• Email: melissa.lavallee@icm-mhi.org
• Phone: 1-514-376-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.