Physicians

CERT – Coronary Event Risk Test (brand name Hertta) is a new test to assess the patient’s risk for severe cardiovascular events, such as myocardial infarction, stroke, and cardiac death. Also CERT measures the risk of type 2 diabetes onset.

CERT is a blood sample based diagnostic method to measure the risk of severe cardiovascular events: myocardial infarction, cardiac death, and stroke. The test also measures risk of type 2 diabetes. The test is based on quantification of certain ceramide lipid molecules.

The test gives as a result two risk scores:

1. Cardiovascular Risk Score (S -CVrisk) and a risk-based statement.
2. Diabetes Risk Score (S -DMrisk) and a risk-based statement.

Cardiovascular Risk

Cardiovascular Risk (S -CVrisk) is divided into four risk categories:

CV Risk Score	Risk Category
0 – 2	Low Risk
3 – 6	Medium Risk
7 – 9	Elevated Risk
10 – 12	High Risk

CERT predicts cardiovascular events more accurately than traditional cholesterol tests. The test also measures the residual risk in patients on cholesterol medication, and predicts myocardial infarction in people who have not yet been diagnosed with coronary artery disease.

Diabetes risk

Diabetes Risk Score reflects a person’s probability to develop a type II diabetes over the next ten years. It is calculated from a specific ceramide ratio and taking into account the person’s body mass index, age and sex.

Diabetes Risk Score (S -DMrisk) is divided into three risk categories:

Diabetes Risk Score	Risk Category
0 – 4	Low Risk
5 – 14	Medium Risk
15 – 100	High Risk

Indications

CERT can be used to predict the risk of myocardial infarction and cardiovascular death, and risk of developing type II diabetes, especially in the following patient groups.

Cardiovascular Risk:

1. People who are not known to have coronary artery disease or elevated cholesterol levels but who, for example have family history of cardiovascular disease or have other risk factors.
2. Men over 40 years old and women over 50 years old to evaluate their risk of cardiovascular events.
3. Coronary artery disease patients and persons on cholesterol-lowering medication to assess their residual risk.

Diabetes Risk:

1. Adults, who are not diagnosed with diabetes.
2. People having family history of type II diabetes or having other risk factors.

Background of ceramide measurements

Ceramides are cell membrane lipids whose levels rise in inflammatory reactions, excessive calorie intake associated with lipid accumulation, or tissue deficiency. Ceramides are associated with several mechanisms of coronary heart disease, for example by accumulating in the arterial plaques and increasing thrombotic risk by activating platelets. Ceramides are also associated to insulin resistance.

By determining ceramides in stable or non-diagnosed patients with coronary artery disease, the assessment of heart attack risk can be refined.

Interpretation of CERT results

For patients with a high CERT score (above 9), it is recommended to intensify treatment or preventive actions. Motivation for treatment and lifestyle changes can be provided by using CERT to flag a more concrete and specific risk for a heart attack or cardiovascular death. In addition, a high-risk score can support decisions to intensify cholesterol lowering medication. In addition, using CERT to monitor the changes in risk will improve patient motivation and commitment to the treatment over a longer period of time.

Patients with a high risk of diabetes are recommended to motivate for lifestyle changes. For example, 5% weight loss or moderate physical activity may reduce the risk. Commitment to life-style change can be supported by raising the more specific risk of type II diabetes. The Diabetes Risk Score measurement can be used to follow-up the effects of lifestyle changes.