NCT05677386Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
Source: ClinicalTrials.gov · Last updated 22 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 6000 (estimated)
- First submitted
- 29 Dec 2022
- Start date
- 20 Mar 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Coronary artery disease
- NCT number
- NCT05677386
What you commit to
- Study type: Interventional
- Planned participants: 6000
- From 20 Mar 2023 to the primary completion date, Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- CTCA related factors
- Known persistent atrial fibrillation
- Known x-ray contrast allergy
- Implanted intracardiac metal devices
- Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
Age
- Statin therapy for \>2 years
Other
- Prior invasive or non-invasive coronary angiography within the last 5 years
- Intolerance of all statins
Who the study is looking for
- Patients must have at least one of the following cardiovascular risk factors:
- \>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
- Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).
Criteria the registry did not label
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.