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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
6,000
Computed tomography coronary angiography (CTCA)
Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction
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
Cardiovascular death or non-fatal acute myocardial infarction
A composite of cardiovascular death or non-fatal acute myocardial infarction
Time frame: 5 years
Acute myocardial infarction
Number of participants with acute myocardial infarction
Time frame: 5 years
Heart failure
Number of participants with heart failure
Time frame: 5 years
Stroke
Number of participants with stroke
Time frame: 5 years
Acute aortic event
Number of participants with acute aortic event
Time frame: 5 years
Cardiovascular Events
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Time frame: 5 years
Death
Number of all-cause deaths
Time frame: 5 years
Coronary cardiovascular procedures
Number of Invasive coronary angiography and coronary revascularisation procedures
Time frame: 5 years
Aortic cardiovascular procedures
Number of percutaneous or surgical treatment of aortic disease
Time frame: 5 years
Aortic valve procedures
Number of percutaneous or surgical treatments of aortic valve disease
Time frame: 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
Time frame: 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
Time frame: 2 years
Prescriptions
Rates of prescription of preventative therapies
Time frame: 5 years
CTCA- incidental findings
Number of participants with incidental findings from CTCA
Time frame: Baseline
CTCA related - radiation dose
Radiation dose at baseline CTCA examination
Time frame: Baseline
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