The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention

The goal of this randomized controlled clinical trial in asymptomatic individuals with risk factors for coronary artery disease is to investigate whether a preventive treatment strategy guided by computed tomography coronary angiography (CTCA) provides a patient-centered approach, which ensures optimal protection against serious heart disease.The main question it aims to answer is:Does preventive treatment guided by CTCA reduce the risk of heart attacks or death as compared to using conventional cardiovascular risk scores.Participants will be randomized to preventive medical therapy and/or invasive intervention guided by either CTCA (intervention group) or Systematic COronary Risk Evaluation (SCORE) 2 model for cardiovascular risk prediction (control group).

Individuals participating in the Copenhagen General Population Study 40 years of age and older, with an estimate glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 will be offered participation in the trial.Inclusion Criteria:Patients must have at least one of the following cardiovascular risk factors:>60 years of ageFamily history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)Hypertension (medically treated, or by clinical assessment)Diabetes mellitusCurrent or recent (within 12 months) smokerKnown hypercholesterolaemia (total cholesterol >6.0 mmol/L or receiving statin therapy)Rheumatoid arthritisSystemic lupus erythematosusChronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).Exclusion Criteria:CTCA related factorsKnown persistent atrial fibrillationKnown x-ray contrast allergyImplanted intracardiac metal devicesKnown coronary heart disease or other major atherosclerotic cardiovascular diseasePrevious coronary revascularizationPrevious myocardial infarctionHeart failureStroke / Transient ischemic attackPeripheral arterial diseasePrior invasive or non-invasive coronary angiography within the last 5 yearsKnown homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapyIntolerance of all statinsStatin therapy for >2 years