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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial

Conditions
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Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases

Intervention / Treatment
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* Diagnostic Test: Primary preventive treatment guided by CTCA
* Other: Cardiovascular risk Score


Participation Criteria
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Eligibility Criteria
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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: >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). Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Primary preventive treatment guided by CTCA | Diagnostic Test: Primary preventive treatment guided by CTCA<br>* Computed tomography coronary angiography (CTCA)<br>* Other names: Wide volume CT;|
| Sham Comparator: Control group<br>Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines. | Other: Cardiovascular risk Score<br>* Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction<br>* Other names: SCORE 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute myocardial infarction | Number of participants with acute myocardial infarction | 5 years | 
| Heart failure | Number of participants with heart failure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, myocardial infarction, CT scans, heart attack