Clinical Evidence

CaRi-Heart® will fundamentally disrupt the approach to diagnosis and treatment of coronary artery disease by predicting heart attacks years before they happen.

This bold claim is backed up by multiple publications in top-tier scientific journals.

Step one

Treating Inflammation reduces cardiovascular adverse events

“Atherosclerosis is an inflammatory disease” (Ross NEJM 1999) and inflammatory pathways predisposing coronary arteries to rupture and thrombosis have been well described (Libby – Mechanisms of ACS – NEJM 2013).

Several randomized controlled trials have shown that inflammation is a valid therapeutic target to reduce cardiovascular events. However, the benefits are only modest in unselected populations, or in populations selected with tests indicating systemic inflammation (e.g. hsCRP).

Apparently healthy persons without hyperlipidemia (low LDL) but with systemic inflammation (elevated hsCRP).

Primary end point
First occurrence of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or confirmed death from cardiovascular causes.

Patients with previous myocardial infarction and residual systemic inflammation (elevated hsCRP).

Primary end point
First occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.

Patients with a recent myocardial infarction ({‘<30’} days) who completed planned PCI and treated with intensive use of statins.

Primary end point
Composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent coronary revascularization.

Stable Patients with evidence of coronary disease by ICA or CCTA, or Calcium score > 400.

Primary end point
Composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization.

Without tests to detect coronary inflammation, it is impossible to target treatments to the people who will benefit most, whilst preventing unnecessary costs and potentially harmful side-effects in people who will not benefit.

It is likely that future clinical trials of treatments to reduce coronary inflammation would show much greater clinical benefits and cost-effectiveness if they were focused on people with high coronary inflammation, identified by CaRi-Heart®.

Step two

FAI is a novel imaging marker of coronary inflammation

Validated against 1400 fat biopsies, from patients undergoing cardiac surgery, with paired CT scans

Measures phenotypic changes in perivascular adipose tissue (adipocytes lipid content and size) in response to inflammation inside the artery

Step three

FAI has prognostic value for cardiac mortality

Quantifying FAI from routine CCTA scans adds major new information to the prediction of cardiovascular risk.


In the CRISP-CT Study, of ~4000 people who underwent a CCTA scan up to 10 years ago and were followed up for cardiovascular events (Oikonomou E et al. Lancet 2018), abnormal FAI was associated with a 6-9x higher risk for fatal heart attacks and 5x higher risk for nonfatal heart attacks over the subsequent years, above-and-beyond all conventional risk factors (such as age, smoking, diabetes, high cholesterol).

The striking predictive power of FAI was also independent of ‘high risk plaque features’, currently reported on CCTA scans.

The presence of high-risk plaque features does not predict increased risk in people who have a low FAI, whereas people with a high FAI have higher risk, even in the absence of high-risk plaque features.

Step four

Using FAI in the CaRi-Heart® Risk provides a personalized cardiovascular risk prediction

Using FAI in clinical practice improves risk stratification and outcomes

Before the clinical manifestations of atherosclerosis become apparent, patient management in primary prevention is based on the control of traditional risk factors (lipids, glucose, blood pressure) and lifestyle education (diet, exercise, smoking cessation).

In secondary prevention, the focus shifts towards symptom relief and the use of non-invasive testing to guide management.

However, over half of acute coronary syndromes occur in patients in whom current diagnostic testing did not reveal evidence of ischemia or a functionally significant coronary artery stenosis.


A CaRi-Heart® report provides comprehensive patient risk stratification for future cardiac events, including:

  • The patient’s relative risk of a fatal cardiac event, compared with people of the same age and gender, based on quantification of the coronary inflammation (FAI-Score)
  • The absolute risk of a fatal cardiac event within the next 8 years, based on the personalised FAI-Score values, the coronary atherosclerotic plaque burden and clinical risk factors


The CaRi-Heart® analysis significantly improves risk discrimination over clinical risk factor-based models across the full spectrum of cardiac risk. One way to seamlessly integrate it into patient management pathways involving CCTA is outlined below:

Compared with Calcium score, CaRi-Heart® has superior prognostic performance