Risk Stratification for Coronary Artery Disease With Type 2 Diabetic Patients

The study is intended as a pilot observational study for evaluation of a new risk scoring method, CADScor System, is relevant for assessment of CAD in the DB2-patient.

The primary end point will be to document that the hypothesis of combining the CADScor System measure with other patient profile data will increase the accuracy of the method for determination of risk of presence of CAD.

The secondary endpoint will be to show that a receiver operating characteristic curve (ROC) of > 80% for correct determination of presence of CAD will be achieved.

The further objective of the study will be to confirm the relevance of performing a large scale study with equivalent objectives.

As controls in the study will be applied CT angiography, CT-calcium and resting and drug induced CT-scintigraphy.

It is assumed that 15-20 of enrolled patients in the study will suffer from CAD.

Inclusion criteria

• Patients suffering from diabetes type 2
• Both sexes
• Patients between 40 and 80 years
• Patients without chest pain at rest and labor
• Patients having a normal electrocardiogram (ECG, i.e. without Q-peaks/ T-peak abnormalities in sinus rhythm)
• Patients having intact skin over sternum

Exclusion criteria

• Patients suffering from a heart disease
• Patients already having received heart surgery
• Patients with pacemaker or other implanted electronic device
• Patients suffering from allergy against iodine and iodine containing substances
• Patients with estimated GFR below 50 ml/min/1.73 sqm m
• Patients suffering from adenosine intolerance or known allergic asthma
• Patients not being capable of understanding the patient information of the study
• Patients who are pregnant
• Patients suffering from allergy to adhesives