VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 273
- 试验地点
- 10
- 主要终点
- Change in LDL cholesterol
研究概览
简要总结
The VICAD-RISK study assesses if visualization of coronary CT angiography (CTA) images in participants with non-obstructive coronary artery disease will improve LDL lowering, reduce reporting of side effects by cholesterol lowering medications, and modify the coronary artery disease phenotype over 12 months.
详细描述
In Denmark, non-obstructive coronary artery disease is found in 35-40% of patients undergoing coronary CT angiography for suspected coronary artery disease. Modification of risk factors is essential in patients with coronary artery disease to prevent major cardiovascular events. However, in non-obstructive coronary artery disease, initiation and adherence to treatment with lipid-lowering therapy is poor.
The study will include 273 patients from 5 different sites; patients will be randomized into 3 groups; standard follow-up by general practice, structured disease education, or the combination of the latter with visualization of coronary CT angiography images. A follow-up CT angiography will be performed at 12 months.
A control group comprising 400 patients with non-obstructive coronary artery disease, stratified based on age, gender, symptoms, and Agatston score, will be identified in the Western Denmark Heart Registry for comparisons with the study groups to assess the influence of study participation on changes in low-density lipoprotein cholesterol.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis of nonobstructive coronary artery disease
- •No known coronary artery disease (no previous coronary revascularization)
- •Coronary Artery Disease Reporting and Data System (CAD-RADS) score 1-3
- •LDL cholesterol > 2.0 mmol/l
- •Life expectancy >3 years
- •Signed informed consent
排除标准
- •Post CTA test indication for invasive coronary angiography
- •Non-evaluable CTA exam
- •Obstructive coronary disease (One or more coronary stenosis ≥70%, left main >40%)
- •Ongoing lipid lowering medical treatment (Patients already on lipid lowering medical therapy can be included if the treatment was initiated <3 months before the time of the CTA test)
- •Renal insufficiency (eGFR <40 ml/min)
- •Allergy to iodinated contrast media
- •Contraindications to statins (Active liver disease Child-Pugh A, B and C, excessive alcohol consumption)
- •Participation in a cardiac rehabilitation or lifestyle modification program
- •Pregnancy
研究组 & 干预措施
Usual care
Usual care follow up in general practice
干预措施: Follow up at general practice (Other)
Low intensity intervention
Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test
干预措施: Consultation (Other)
High intensity intervention
Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test combined with visualization of the individual CTA images with focus on the atherosclerotic findings and the effect of statin treatment on the disease
干预措施: Consultation (Other)
High intensity intervention
Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test combined with visualization of the individual CTA images with focus on the atherosclerotic findings and the effect of statin treatment on the disease
干预措施: Visualization of CTA images (Other)
结局指标
主要结局
Change in LDL cholesterol
时间窗: 12 months
Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up
次要结局
- Side effects of statin therapy(12 months)
- Changes in high risk coronary plaque volumes(12 months)
- Proportion of patients adherent to statin (%)(12 months)
- Change in high-sensitive CRP(12 months)
- Change in HbA1c(12 months)
- Change in total-cholesterol levels(12 months)
- Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level)(12 months)
- Change in dietary, exercise, and smoking habits(12 months)
- Change in Angina and Quality of Life-scores(12 months)
- Adverse clinical events (%)(12 months)
- Change in blood pressure(12 months)
- Change in Body Mass Index(12 months)
- Use of cardiovascular medication(12 months)
- Change in high-sensitive C-reactive Protein(12 months)
研究者
Bjarne Linde Nørgaard
MD, Professor, DMSCi, PhD
Aarhus University Hospital