CERT – Coronary Event Risk Test

Cardiovascular diseases are the leading cause of death worldwide, causing more deaths than cancer today

Unmet need in Cardiovascular Disease Prevention and Treatment

The increased risk for fatal cardiovascular events may not be apparent in routine patient evaluations. It is important to note that more than half of patients hospitalized with an heart attack have normal LDL-C levels. Thus, high risk coronary artery disease (CAD) patients may have similar or even lower LDL-C concentrations than patients with more favorable prognosis. CAD may not even cause any apparent symptoms and the first symptom can be cardiovascular death.

LDL-C lowering with statins reduces major coronary events by 25%, however 75% of coronary events still manifest despite this treatment. Also, majority of patients with established coronary heart disease, underestimate their risk for a future coronary event. Risk stratification should be improved to predict coronary events and to optimize treatment strategies both in primary and secondary prevention.

It is essential to identify patients who are at high risk for a severe outcome and treat them effectively in a timely fashion. Especially those who are believed to be at target with treatment goals may benefit from further testing with CERT. CERT is a helpful indicator for CAD patients as it identifies high-risk individuals among statin treated CAD patients.


How does CERT work?

Coronary Event Risk Test (CERT) predicts the risk for non-fatal and fatal coronary artery disease events

CERT provides an assessment of the patient’s future risk for having a serious coronary event. CERT is performed using mass spectrometry measurement of blood based marker molecule levels and calculating a risk score.

CERT improves risk stratification as it predicts coronary events both in stable CAD and ACS patients, enabling optimization of secondary prevention strategies.

CERT can be used for estimating residual coronary event risk of patients on cholesterol lowering medication.

Importantly, CERT may help in identifying those high-risk patients that should receive additional lipid lowering therapy, whether it is higher statin doses or novel, but costly, treatments such as PCSK9 inhibitors.


CERT indications:

  • Primary prevention screening, for example, in routine occupational health care screening such as a medical check-up for 50-year olds
  • Individuals with known family history of premature CAD
  • Patients with stable angina
  • All other secondary prevention patients
  • Statin treated individuals

 Actions based on CERT Score risk assessment

  • Medication can be initiated earlier
  • Motivate patient’s adherence to medication
  • Motivate patient to life-style changes
  • More frequent follow-up visits to monitor the high risk patient
  • Adjust treatment regimen of the patient: consideration for higher statin doses or ezetimibe combinations
  • Consider possible novel therapies such as PCSK9 inhibitors


CERT Score and risk for cardiovascular death

CERT Score is calculated based on four ceramide molecules and their ratios. CERT Score is used to assess the patient’s risk level

BECAC (5-year risk)

Cert scoreDeaths %Relative Risk
0-22.7 %1.0
3-64.8 %1.8
7-96.9 % 2.5
10-1211.4 %4.2
LDL-C (mg/dl)Deaths %Relative Risk
≤1006.6 %1.0
100-1434.8 %0.7
143-1753.5 %0.5
≥1754.1 %0.6

SPUM-ACS (1-year risk)

Cert scoreDeaths %Relative Risk
0-21.6 %1.0
3-62.6 %1.7
7-93.3 %2.1
10-129.4 %6.0
LDL-C (mg/dl)Deaths %Relative Risk
≤1064.8 %1.0
106-1452.9 %0.6
145-1741.1 %0.2
≥1741.1 %0.2

Comparison of CERT Score performance to LDL-C. BECAC n=1580, SPUM-ACS n=1637. Ref: Laaksonen et al. Eur Heart J 2016