AI medical trial: AI echocardiography to detect cardiac amyloidosis — a clinical trial (ClinicalTrials.gov)

1Cardiac amyloidosis is hard to catch

Cardiac amyloidosis is a disease in which misfolded protein is deposited in the heart muscle, causing mainly heart-failure symptoms. It often produces heart failure even though the left ventricle's pumping function (ejection fraction) is preserved, and it shows certain features on echocardiography such as thickened (hypertrophied) walls.

Because it can resemble other heart conditions, identifying it with currently available echocardiographic tools remains challenging. Early diagnosis matters greatly, since it can connect patients to therapies that have improved survival.

2Reading echocardiograms with an algorithm

This study (NCT07529860) is a prospective study testing how accurately an AI algorithm applied to echocardiographic images (the software Us2.ai) can pick up patients with findings suggestive of cardiac amyloidosis, especially the transthyretin (ATTR) type.

Crucially, it does not treat the AI's output as the answer: accuracy is judged against methods that actually establish the diagnosis — bone-tracer SPECT (using 99mTc-pyrophosphate, PYP), cardiac MRI, and blood tests, with tissue confirmation if needed — used as ground truth.

Echocardiography is the first-choice test for patients with breathlessness or suspected heart failure, and for those with risk factors such as hypertension and diabetes. Layering AI onto these routine scans could widen the chance of catching the disease earlier.

3Not treating the AI's call as truth

What matters in the design is that the AI's determination is not taken as the answer. Methods that actually establish the diagnosis are placed as the standard.

1. 1AI reads the echocardiogramThe software identifies patients with findings suggesting cardiac amyloidosis
2. 2Its call is not the truthBy design it is not taken as the reference
3. 3Diagnostic methods are the standardBone scintigraphy, cardiac MRI, blood tests, and tissue confirmation if needed
4. 4Accuracy and prevalence togetherTrue prevalence among those with red-flag findings is also established

Cardiac amyloidosis often causes heart failure with preserved ejection fraction and is easily confused with other cardiac disease. Echocardiography is the first test chosen for suspected breathlessness or heart failure, so laying an AI reading over it could widen the chance of picking the disease up from an ordinary echo.