Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis

Launched by ALGALARRONDO VINCENT · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of artificial intelligence (AI) to help identify a specific heart condition called transthyretin cardiac amyloidosis (ATTR-CM) through a common heart test called echocardiography. The goal is to see if the AI can accurately diagnose different types of ATTR-CM, which can affect the heart's ability to pump blood effectively. This study is non-interventional, meaning participants will not receive any experimental treatment; instead, their echocardiogram images will be used to train and test the AI program.

To be eligible for the study, patients must have a confirmed diagnosis of ATTR-CM based on specific medical criteria, such as a positive heart biopsy or imaging results. Control participants who do not have ATTR-CM but need an echocardiogram for routine heart checks can also join. If you participate, you can expect your echocardiogram data to contribute to important research that may improve the diagnosis of this heart condition in the future. It’s important to know that the study is currently recruiting participants aged 65 to 74, and both men and women are welcome to take part.

Gender

ALL

Eligibility criteria

• ATTR-CM patients:
• Inclusion Criteria:
• * Cardiac transthyretin amyloidosis diagnosed on the classic criteria:
• • 1. Absence of monoclonal immunoglobulin AND
• • 2. Presence of a bisphosphonate scintigraphy with enhancement in the cardiac area OR
• • 2-Presence of a cardiac biopsy showing transthyretin (Congo red positive) cardiac amyloidosis (demonstrated either by immunostaining or by mass spectrometry) OR 3-Presence of a peripheral biopsy showing transthyretin amyloidosis (see above) associated with cardiac infiltration (parietal thickness \>12mm without other cause of cardiac hypertrophy)
• • No opposition to research
• Non-inclusion criteria:
• • Another cause of cardiac amyloidosis: AL AA amyloidosis...
• • Mixed heart disease with associated presence of non-amyloid heart disease (ischemic heart disease, dilated, etc.)
• Control patients:
• Inclusion criteria:
• • Indication for transthoracic echocardiography as part of cardiological follow-up
• • Patient affiliated with social security
• • Patient's agreement to participate in the research and signature of the consent form.
• • Technical conditions of the examination and echogenicity allowing acquisition of good quality echocardiographic images, allowing post processing
• Non-inclusion criteria:
• • Presence of cardiac amyloidosis as defined above
• • Presence of transthyretin amyloidosis even without demonstrated cardiac involvement
• • Patient monitored for asymptomatic transthyretin mutation
• • Minor patient or patient unable to give their consent (unconscious patient, under guardianship)