2 The technology

The intervention

2.1 CaRi‑Heart (Caristo Diagnostics) is a medical imaging analysis software that uses artificial intelligence (AI) to analyse images from CT coronary angiography (CTCA).

The comparator

2.2 The comparator was CTCA plus clinical assessment of risk factors for cardiovascular disease (CVD), such as hypertension, diabetes, dyslipidaemia, smoking, and a family history of CVD.

Clinical need

2.3 Coronary artery disease (CAD) affects the arteries that supply blood to the heart muscle. Fatty plaques can build up on the walls of these arteries, narrowing them. This reduces blood flow and can result in angina and heart attack. Heart attack risk is also linked to inflammation in the wall of the artery. This can cause plaque to form and rupture, which can block an artery, leading to acute coronary syndrome or sudden death.

2.4 In current standard practice people with recent-onset chest pain are referred to have a CTCA, which is non-invasive and visualises coronary arteries to identify abnormalities such as plaque build-up and narrowing. But CTCA scans do not identify inflammation in coronary arteries.

2.5 CaRi‑Heart can identify inflammation, and its extent, by analysing images from CTCA scans. It aims to identify risk of cardiac mortality with greater discrimination than the currently used clinical risk-factor based models and improve outcomes by personalising prevention and treatment.