The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
- Conditions
- Coronary Atherosclerosis and Other Heart DiseaseCardiovascular Diseases
- Interventions
- Diagnostic Test: Primary preventive treatment guided by CTCAOther: Cardiovascular risk Score
- Registration Number
- NCT05677386
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief 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 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 6000
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).
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Primary preventive treatment guided by CTCA Primary preventive treatment guided by CTCA Control group Cardiovascular risk Score Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines.
- Primary Outcome Measures
Name Time Method Cardiovascular death or non-fatal acute myocardial infarction 5 years A composite of cardiovascular death or non-fatal acute myocardial infarction
- Secondary Outcome Measures
Name Time Method Stroke 5 years Number of participants with stroke
CTCA related - radiation dose Baseline Radiation dose at baseline CTCA examination
Acute myocardial infarction 5 years Number of participants with acute myocardial infarction
Heart failure 5 years Number of participants with heart failure
Death 5 years Number of all-cause deaths
Aortic valve procedures 5 years Number of percutaneous or surgical treatments of aortic valve disease
Prescriptions 5 years Rates of prescription of preventative therapies
Acute aortic event 5 years Number of participants with acute aortic event
Cardiovascular Events 5 years Number of participants who have fatal and non-fatal myocardial infarction or stroke
CTCA- incidental findings Baseline Number of participants with incidental findings from CTCA
Aortic cardiovascular procedures 5 years Number of percutaneous or surgical treatment of aortic disease
Quality of Life (EQ-5D-5L) 2 years Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100
Coronary cardiovascular procedures 5 years Number of Invasive coronary angiography and coronary revascularisation procedures
Trial Locations
- Locations (2)
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
🇩🇰Herlev, Denmark
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
🇩🇰Copenhagen, Denmark