Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 6,000
- 试验地点
- 4
- 主要终点
- Cardiovascular death or non-fatal acute myocardial infarction
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Cardiovascular death or non-fatal acute myocardial infarction
时间窗: 5 years
A composite of cardiovascular death or non-fatal acute myocardial infarction
次要结局
- Stroke(5 years)
- CTCA related - radiation dose(Baseline)
- Acute myocardial infarction(5 years)
- Heart failure(5 years)
- Death(5 years)
- Aortic valve procedures(5 years)
- Prescriptions(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)
- Coronary cardiovascular procedures(5 years)
研究者
Klaus Fuglsang Kofoed
Principle Investigator
Rigshospitalet, Denmark