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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
| University of Copenhagen | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary preventive treatment guided by CTCA | Diagnostic Test | Computed tomography coronary angiography (CTCA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death or non-fatal acute myocardial infarction | A composite of cardiovascular death or non-fatal acute myocardial infarction | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute myocardial infarction | Number of participants with acute myocardial infarction | 5 years |
| Heart failure | Number of participants with heart failure |
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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:
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
Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
Intolerance of all statins
Statin therapy for >2 years
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| Name | Affiliation | Role |
|---|---|---|
| Klaus F Kofoed, MD,SmSc | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen | Copenhagen | 2100 | Denmark |
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.
1 year after publication of main results
Requests by email in 2030
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| Cardiovascular risk Score | Other | Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction |
|
|
| 5 years |
| Stroke | Number of participants with stroke | 5 years |
| Acute aortic event | Number of participants with acute aortic event | 5 years |
| Cardiovascular Events | Number of participants who have fatal and non-fatal myocardial infarction or stroke | 5 years |
| Death | Number of all-cause deaths | 5 years |
| Coronary cardiovascular procedures | Number of Invasive coronary angiography and coronary revascularisation procedures | 5 years |
| Aortic cardiovascular procedures | Number of percutaneous or surgical treatment of aortic disease | 5 years |
| Aortic valve procedures | Number of percutaneous or surgical treatments of aortic valve disease | 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 | 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 | 2 years |
| Prescriptions | Rates of prescription of preventative therapies | 5 years |
| CTCA- incidental findings | Number of participants with incidental findings from CTCA | Baseline |
| CTCA related - radiation dose | Radiation dose at baseline CTCA examination | Baseline |
| The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark | Herlev | 2730 | Denmark |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D000082742 | Heart Disease Risk Factors |
| ID | Term |
|---|---|
| D012307 | Risk Factors |
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D015984 | Causality |
| D015981 | Epidemiologic Factors |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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