Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 6,000
- Locations
- 2
- Primary Endpoint
- Cardiovascular death or non-fatal acute myocardial infarction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Intervention group
Primary preventive treatment guided by CTCA
Intervention: Primary preventive treatment guided by CTCA (Diagnostic Test)
Control group
Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines.
Intervention: Cardiovascular risk Score (Other)
Outcomes
Primary Outcomes
Cardiovascular death or non-fatal acute myocardial infarction
Time Frame: 5 years
A composite of cardiovascular death or non-fatal acute myocardial infarction
Secondary Outcomes
- Stroke(5 years)
- Coronary cardiovascular procedures(5 years)
- Death(5 years)
- Prescriptions(5 years)
- CTCA related - radiation dose(Baseline)
- Aortic valve procedures(5 years)
- Acute myocardial infarction(5 years)
- Heart failure(5 years)
- Acute aortic event(5 years)
- Cardiovascular Events(5 years)
- CTCA- incidental findings(Baseline)
- Aortic cardiovascular procedures(5 years)
- Quality of Life (EQ-5D-5L)(2 years)
- Quality of Life (EQ-5D-5L)(6 months)
Investigators
Klaus Fuglsang Kofoed
Principle Investigator
Rigshospitalet, Denmark