Coronary Atherosclerosis and Other Heart DiseaseNCT05677386
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
A study testing Primary preventive treatment guided by CTCA and Cardiovascular risk Score in people with Coronary Atherosclerosis and Other Heart Disease and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
- What is being tested?
- Primary preventive treatment guided by CTCA and Cardiovascular risk Score
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Mar 2023to Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- CTCA related factors
- Known persistent atrial fibrillation
- Known x-ray contrast allergy
- Implanted intracardiac metal devices
- Known coronary heart disease or other major atherosclerotic cardiovascular disease
- Previous coronary revascularization
Show all 14Show fewer
- Previous myocardial infarction
- Heart failure
- Stroke / Transient ischemic attack
- Peripheral arterial disease
- Prior invasive or non-invasive coronary angiography within the last 5 years
- Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
- Intolerance of all statins
- Statin therapy for >2 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
Copenhagen, 2100
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
Herlev, 2730
About this study
Official title: Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
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:
Read more
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).
Read the detailed description
The following hypothesis will be tested:
Primary hypothesis: Primary preventive treatment guided by CTCA reduces the risk of myocardial infarction and cardiovascular death compared to standard care in individuals with risk factors for cardiovascular disease.
Additional objectives that will be addressed in the trial include the impact of a CTCA guided preventive treatment strategy compared to standard care with regards to quality of life, adherence to pharmacological preventive therapy, frequency of invasive diagnostic and therapeutic cardiovascular procedures in addition to health economic assessment of cost-effectiveness.
Trial Design
The DANE-HEART Trial is an investigator-initiated, prospective, open label, parallel group, randomized controlled trial assessing the effect of a CTCA guided preventive treatment strategy. Consecutive individuals at risk of cardiovascular disease will be included and randomized 1:1 to the following strategies
Intervention group: Primary preventive treatment guided by CTCA
Control group: Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 risk assessment model according to Danish clinical guidelines.
Patient Cohort
Individuals participating in the Copenhagen General Population Study will be offered participation in the trial. A total of 8000 individuals will be included, or when 6000 individuals have been randomized.
- Being tested
- Primary preventive treatment guided by CTCA, Cardiovascular risk Score
- Keywords
- cardiovascular disease, myocardial infarction, CT scans, heart attack
- Medical subject headings
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary preventive treatment guided by CTCADiagnostic test
Also called Wide volume CT
Computed tomography coronary angiography (CTCA)
Cardiovascular risk ScoreOther
Also called SCORE 2
Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Primary preventive treatment guided by CTCA Receives: Diagnostic Test: Primary preventive treatment guided by CTCA |
| Control group | Sham comparator | Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines. Receives: Other: Cardiovascular risk Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death or non-fatal acute myocardial infarction
A composite of cardiovascular death or non-fatal acute myocardial infarction
Measured: 5 years
Secondary outcomes (14)
Acute myocardial infarction
Number of participants with acute myocardial infarction
Measured: 5 years
Heart failure
Number of participants with heart failure
Measured: 5 years
Stroke
Number of participants with stroke
Measured: 5 years
Acute aortic event
Number of participants with acute aortic event
Measured: 5 years
Cardiovascular Events
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Measured: 5 years
Death
Number of all-cause deaths
Measured: 5 years
Coronary cardiovascular procedures
Number of Invasive coronary angiography and coronary revascularisation procedures
Measured: 5 years
Aortic cardiovascular procedures
Number of percutaneous or surgical treatment of aortic disease
Measured: 5 years
Aortic valve procedures
Number of percutaneous or surgical treatments of aortic valve disease
Measured: 5 years
Quality of Life (EQ-5D-5L)
Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100
Measured: 6 months
Quality of Life (EQ-5D-5L)
Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100
Measured: 2 years
Prescriptions
Rates of prescription of preventative therapies
Measured: 5 years
CTCA- incidental findings
Number of participants with incidental findings from CTCA
Measured: Baseline
CTCA related - radiation dose
Radiation dose at baseline CTCA examination
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start20 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Atherosclerosis and Other Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen
- Responsible party
- Principal investigator, Klaus Fuglsang Kofoed, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Klaus F Kofoed, MD,SmSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677386
- Sponsor's protocol ID
- DANE-HEART trial
- Status last verified
- Nov 2026
- First submitted
- 29 Dec 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The intention is to share anonymised data with external collaborators and scientists in according to General Data Protection Regulation rules and Danish laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
- ClinicalTrials.gov ID
- NCT05677386
- Acronym / sponsor ID
- DANE-HEART trial
- Keywords
- cardiovascular disease, myocardial infarction, CT scans, heart attack
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The following hypothesis will be tested:
Primary hypothesis: Primary preventive treatment guided by CTCA reduces the risk of myocardial infarction and cardiovascular death compared to standard care in individuals with risk factors for cardiovascular disease.
Additional objectives that will be addressed in the trial include the impact of a CTCA guided preventive treatment strategy compared to standard care with regards to quality of life, adherence to pharmacological preventive therapy, frequency of invasive diagnostic and therapeutic cardiovascular procedures in addition to health economic assessment of cost-effectiveness.
Trial Design
The DANE-HEART Trial is an investigator-initiated, prospective, open label, parallel group, randomized controlled trial assessing the effect of a CTCA guided preventive treatment strategy. Consecutive individuals at risk of cardiovascular disease will be included and randomized 1:1 to the following strategies
Intervention group: Primary preventive treatment guided by CTCA
Control group: Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 risk assessment model according to Danish clinical guidelines.
Patient Cohort
Individuals participating in the Copenhagen General Population Study will be offered participation in the trial. A total of 8000 individuals will be included, or when 6000 individuals have been randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Diagnostic Test: Primary preventive treatment guided by CTCAPrimary preventive treatment guided by CTCA |
| Control group | Sham comparator | Other: Cardiovascular risk ScorePrimary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >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
Key exclusion criteria (14 listed)
- 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
- Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
- Intolerance of all statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary preventive treatment guided by CTCAAlso: Wide volume CTComputed tomography coronary angiography (CTCA) | Diagnostic test | Intervention group |
| Cardiovascular risk ScoreAlso: SCORE 2Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction | Other | Control group |
Primary outcome
Cardiovascular death or non-fatal acute myocardial infarction
Time frame: 5 years
A composite of cardiovascular death or non-fatal acute myocardial infarction
14 secondary outcomes
Acute myocardial infarction
Time frame: 5 years
Heart failure
Time frame: 5 years
Stroke
Time frame: 5 years
Acute aortic event
Time frame: 5 years
Cardiovascular Events
Time frame: 5 years
Death
Time frame: 5 years
Coronary cardiovascular procedures
Time frame: 5 years
Aortic cardiovascular procedures
Time frame: 5 years
Aortic valve procedures
Time frame: 5 years
Quality of Life (EQ-5D-5L)
Time frame: 6 months
Quality of Life (EQ-5D-5L)
Time frame: 2 years
Prescriptions
Time frame: 5 years
CTCA- incidental findings
Time frame: Baseline
CTCA related - radiation dose
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. The intention is to share anonymised data with external collaborators and scientists in according to General Data Protection Regulation rules and Danish laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Klaus F Kofoed, MD,SmSc principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary preventive treatment guided by CTCA and Cardiovascular risk Score in people with Coronary Atherosclerosis and Other Heart Disease and Cardiovascular Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death or non-fatal acute myocardial infarction (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.