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Clinical Trials in Denmark / NCT05677386
Enrolling by invitation Not applicable

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

NCT05677386 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2023-03-20
Last updated
2023-03-22

Condition(s) studied

Coronary Atherosclerosis and Other Heart DiseaseCardiovascular Diseases

Investigational drug(s) / intervention(s)

Primary preventive treatment guided by CTCACardiovascular risk Score

Primary preventive treatment guided by CTCA: Computed tomography coronary angiography (CTCA)

Cardiovascular risk Score: Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
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: 1. \>60 years of age 2. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years) 3. Hypertension (medically treated, or by clinical assessment) 4. Diabetes mellitus 5. Current or recent (within 12 months) smoker 6. Known hypercholesterolaemia (total cholesterol \>6.0 mmol/L or receiving statin therapy) 7. Rheumatoid arthritis 8. Systemic lupus erythematosus 9. Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2). Exclusion Criteria: 1. CTCA related factors * Known persistent atrial fibrillation * Known x-ray contrast allergy * Implanted intracardiac metal devices 2. Known coronary heart disease or other major atherosclerotic cardiovascular disease * Previous coronary revascularization * Previous myocardial infarction * Heart failure * Stroke / Transient ischemic attack * Peripheral arterial disease 3. Prior invasive or non-invasive coronary angiography within the last 5 years 4. Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy 5. Intolerance of all statins 6. Statin therapy for \>2 years

Primary outcome measure(s)

  • Cardiovascular death or non-fatal acute myocardial infarction — 5 years
    A composite of cardiovascular death or non-fatal acute myocardial infarction

Trial sites (2)

FacilityCityRegionStatus
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Copenhagen Denmark
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark Herlev Denmark

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Other trials for the same condition

The Nordic Aortic Valve Intervention Trial 4 (NOTION-4) Active, not recruiting
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT Active, not recruiting
The Oxford Risk Factors And Non-Invasive Imaging Study Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure Recruiting
Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05677386 on ClinicalTrials.gov ↗ ← All trials in Denmark