Using AI to help identify cardiac amyloidosis through echocardiography

Artificial Intelligence to Assist the Echocardiographic Identification of Transthyretin Cardiac Amyloidosis

This study is testing a new artificial intelligence tool to see if it can help doctors find a heart condition called cardiac amyloidosis more quickly using standard heart ultrasound images.

Quick facts

• Study type: Observational
• Enrollment: 15000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bichat Hospital (other)
• Locations: 1 site (Paris)
• Trial ID: NCT06328075 on ClinicalTrials.gov

What this trial studies

This observational study aims to develop an artificial intelligence algorithm to assist in the identification of transthyretin cardiac amyloidosis (ATTR-CM) using routine transthoracic echocardiography. The study will analyze deidentified echocardiographic data to train, validate, and test the algorithm's ability to diagnose different types of ATTR-CM. By improving early diagnosis, the study seeks to enhance patient outcomes through timely treatment initiation. The research focuses on addressing the challenges of missed or delayed diagnoses in patients with cardiac involvement.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with cardiac transthyretin amyloidosis based on established clinical criteria.

Not a fit: Patients with other causes of cardiac amyloidosis or mixed heart disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of cardiac amyloidosis, allowing patients to receive timely treatment.

How similar studies have performed: Other studies utilizing AI for diagnostic purposes in cardiology have shown promise, indicating potential success for this approach.

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)

Where this trial is running

Paris

• Bichat — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Vincent Algalarrondo, MD, PhD

Conditions: Amyloid Cardiomyopathy, Transthyretin Amyloid Cardiomyopathy, Transthyretin Cardiac Amyloidosis, echocardiography, artificial intelligence