The overall aim of this project is to provide a comprehensive summary of all available evidence that may be relevant to the evaluation of CaRi-Heart® [a cloud-based CE-marked medical device (Caristo Diagnostics Ltd, Oxford, UK) that analyses images from computed tomography coronary angiography (CTCA) scans to provide information about inflammation in the coronary arteries], as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease (CAD), who are undergoing CTCA. This assessment does not include the development of an executable cost-effectiveness model but does include conceptual modelling which explores the structure and evidence about parameters required for model development (see Chapter 5).

Current National Institute for Health and Care Excellence (NICE) guidelines do not include recommendations about the use of formal risk assessment tools, or intervention(s) based on specific risk thresholds, in this patient group. This Early Value Assessment (EVA), therefore, includes exploration of the potential clinical consequences of the availability of additional risk information from CaRi-Heart.

Given the anticipated limitations of the evidence base, the NICE scope for this assessment¹ is broad and includes some evidence about secondary outcomes (Table 1). These outcomes may be used to inform consideration of the potential benefits of implementing CaRi-Heart, as specified in the scope, and to guide further research to enable full assessment of clinical efficacy and safety.

TABLE 1

Inclusion criteria

Based on the NICE scope,¹ we have defined a series of research questions that could inform both a full assessment of the clinical and cost effectiveness of using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected CAD, who are undergoing CTCA and consideration of the potential of this technology to be cost-effective:

1. What is the prognostic performance of CaRi-Heart, in people with stable chest pain, who are undergoing CTCA, where:
   1. the dependent variable is cardiac death?
   2. the dependent variable is other major adverse cardiovascular events (MACE)?
2. What is the prevalence of ‘low’, ‘medium’ and ‘high’ CaRi-Heart Risk in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging?
3. What are the clinical effects of using CaRi-Heart to assess cardiac risk?
   1. How does CaRi-Heart Risk affect treatment decisions and patient adherence in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging?
   2. What are the clinical effects of any changes to treatment, based on CaRi-Heart Risk, in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging?
4. What are the costs, from a UK NHS and Personal Social Services (PSS) perspective, using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain, who are undergoing CTCA?
5. How might a conceptual model be specified in terms of structure and evidence required for parameterisation in order to estimate the cost effectiveness of CaRi-Heart in people with stable chest pain, who are undergoing CTCA?

The above questions were defined in line with the NICE scope¹ and have been used to inform the inclusion criteria for the rapid review component of this assessment (see Table 1). In addition to the rapid review, evidence that may be required to inform parameterisation of a future cost-effectiveness model has been explored, as part of the conceptual modelling process (see What are the costs, from a UK NHS and Personal Social Services perspective, of using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain, who are undergoing computed tomography coronary angiography? and Chapter 5), using a pragmatic, iterative searching approach; model parameterisation questions, other than costs, were not included in the rapid review.

The available evidence is summarised, with consideration of its relevance to the above research questions, and a detailed description of evidence gaps where further research is needed is provided (see Strengths and limitations).