The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention (NCT05677386) | Clinical Trial Compass
By InvitationNot Applicable
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Denmark6,000 participantsStarted 2023-03-20
Plain-language summary
The goal of this randomized controlled clinical trial in asymptomatic individuals with risk factors for cardiovascular 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 cardiovascular disease.
The main question it aims to answer is:
Does preventive treatment guided by CTCA reduce the risk of heart attacks or cardiovascular 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).
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. \>60 years of age
✓. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
✓. Hypertension (medically treated, or by clinical assessment)
✓. Diabetes mellitus
✓. Current or recent (within 12 months) smoker
✓. Known hypercholesterolaemia (total cholesterol \>6.0 mmol/L or receiving statin therapy)
✓. Rheumatoid arthritis
✓. Systemic lupus erythematosus
Exclusion criteria
✕. CTCA related factors
✕. Known coronary heart disease or other major atherosclerotic cardiovascular disease
✕. Prior invasive or non-invasive coronary angiography within the last 5 years
What they're measuring
1
Cardiovascular death or non-fatal acute myocardial infarction