RecruitingOBSERVATIONAL

Non-ischemic Cardiomyopathy Registry, Biobank and Imaging Data Repository

This research project, called CaNICM, is creating a central database, a collection of samples (biobank), and imaging information for people with a heart condition called non-ischemic cardiomyopathy (NICM). It also includes their close family members who might be at risk, even if they don't have symptoms yet. The main goals are to better predict serious heart rhythm problems in NICM patients, figure out the best way to check their family members (who to test, when, and how), and discover early treatments to prevent or slow down the disease in those at risk. In the future, the study will test how well these new prediction methods work compared to current approaches, helping to improve care for NICM patients and their families.

At a glance

Status

Recruiting

Sponsor

Montreal Heart Institute

Enrolment target

2,000

Start

02 Apr 2024

Estimated completion

01 Apr 2031

Non-ischemic Cardiomyopathy

What is this study about?

This research study is all about understanding a heart condition called non-ischemic cardiomyopathy, or NICM for short. This is a type of heart muscle disease that isn't caused by blockages in the heart's blood vessels. The study wants to create a big, central collection of information, including medical details, blood samples (a 'biobank'), and heart scan images from people with NICM. It will also gather information from their closest family members, especially those who might carry specific genes that could lead to NICM, even if they don't have symptoms themselves yet.

The main idea behind this project is to learn more about NICM. By looking at all this information together, researchers hope to get better at predicting who might be at higher risk of developing serious heart rhythm problems. They also want to find the best ways to check family members who might be at risk, so they know exactly who should be tested, when, and what kind of tests are most useful. Ultimately, this research aims to help doctors find better ways to treat family members early on, which could prevent or slow down the disease.

In the future, the researchers plan to test how well their new ways of predicting risk work in real-life situations. They'll compare these new methods with the way doctors currently assess risk to see if the new approach is more effective. This study is really important because it could lead to much better care and earlier interventions for people with NICM and their families, potentially improving their heart health and quality of life.

Key takeaways

This study aims to understand a heart condition called non-ischemic cardiomyopathy (NICM).
It collects medical data, heart scans, and blood samples from patients and at-risk family members.
The goal is to improve risk prediction, family screening, and early treatment for NICM.
Your privacy is protected, and data is made anonymous.
Participation involves sharing medical history, existing scans, and giving blood samples.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to have non-ischemic cardiomyopathy. This means your heart's main pumping chamber (left ventricle) works with less than 50% of its normal strength, or between 50-55% if scans show specific scarring or an enlarged heart, and you have a particular gene change linked to NICM.

There are several reasons why you might not be able to join. For example, if your heart problem is mainly caused by blocked arteries, severe valve issues, certain other specific heart conditions like Amyloid heart disease, or if you've already had a heart transplant. Also, if there's a very clear reason for your heart problem, like specific drug use or alcohol, that completely explains your condition, you might not be eligible unless your doctor thinks otherwise.

The study welcomes people of all ages and genders. Although it's mainly for adults, children might also be included. There's a small limit on the number of patients over 70 who can join from each centre, but having risk factors like a history of chemotherapy or radiation doesn't automatically exclude you, unless your doctor believes these factors fully explain your heart condition.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a heart condition called non-ischemic cardiomyopathy?
Is your heart's pumping strength (LVEF) usually less than 50%?
Or, is your LVEF between 50-55% with specific heart scan findings and a known NICM gene change?
Do you *not* have severe heart problems like severe artery blockages or significant valve disease causing your condition?
Have you *not* had a heart transplant already?
Are you able to provide written agreement to take part?

Answer every question to see your result.

What does participation involve?

If you are interested and eligible, a local research team member will contact you to explain the study in detail and discuss what's involved. You'll have plenty of time to ask questions and think about whether you want to participate before giving your written agreement.

Taking part would involve giving permission for researchers to collect your past medical information from your electronic records and from a questionnaire you would fill out. They would also collect existing heart scan images, like MRI and ultrasound scans (CMR and TTE), and heart tracings (ECGs).

You would also be asked to provide blood samples for the 'biobank', which is a collection of samples stored for future research. All of your personal health information will be kept strictly private and coded with a unique study number to protect your identity. You can decide to leave the study at any time.

Potential risks and benefits

The main benefit of taking part is contributing to research that could lead to better understanding, prediction, and treatment for non-ischemic cardiomyopathy for future patients and their families. While there's no direct personal medical benefit from participating, your information is incredibly valuable. The risks are generally low, mainly involving the minor discomfort of blood draws, and the time taken for consultations and questionnaires. All your personal data will be kept confidential and coded to protect your privacy. Remember, you can withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Montreal Heart Institute
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is 'Non-ischemic Cardiomyopathy (NICM)'?

NICM is a heart muscle disease where the heart struggles to pump blood effectively, but it's not caused by blockages in the heart's arteries.

Why are family members being included in the study?

Some forms of NICM can run in families due to genetic changes. Including family members helps researchers understand how these conditions develop and how best to screen and treat those at risk.

Will I receive any direct treatment by joining this study?

This study is focused on gathering information and samples for research. It doesn't offer direct treatment, but your contribution will help improve future treatments for NICM.

Is my personal information safe?

Yes, your privacy is very important. All your health information will be made anonymous by replacing your personal details with a unique study code.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Melissa Lavallée

melissa.lavallee@icm-mhi.org 1-514-376-3330 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.