CaRi-Heart for predicting cardiac risk in suspected coronary artery disease: early value assessment

Further research is recommended to address the uncertainty around clinical outcomes for people with suspected coronary artery disease (CAD) undergoing CT coronary angiography (CTCA) for chest pain who have had CaRi‑Heart testing. The committee said that a clinical outcome study using CaRi‑Heart to determine a treatment strategy with people followed up for long enough to observe a reduction in cardiac events or death would be ideal. But because this may be difficult it agreed that a linked evidence approach would be acceptable (see section 3.10). The studies identified by the external assessment group (EAG) demonstrated the link between treating inflammation more generally in people with cardiovascular disease and reducing cardiac events or death, but were not able to address coronary inflammation. The committee agreed that further studies were needed (see section 3.10). Data on groups defined by CTCA (no CAD, non-obstructive CAD and obstructive CAD) would also be useful.

Further data on how CaRi‑Heart affects clinical decision making and clinical management compared with UK standard clinical practice (CTCA alongside clinical risk assessment) should be collected (see section 3.8 and section 3.9). QRISK3 should be included as a comparator for people who have no CAD identified on CTCA (see section 3.5).

External validation of CaRi‑Heart in a UK setting would be useful (see section 3.6). Research should also include groups by sex, age, ethnicity, socioeconomic status, and CAD status if possible (see section 3.7).

Data should be collected on the costs associated with using CaRi‑Heart, including implementation costs, training costs, and impact on costs and resource use later in the treatment pathway (see section 3.12).