VIsualization of Coronary Artery Disease for Modification of RISK Factors
- Conditions
- Coronary Artery DiseaseNon-Obstructive Coronary Atherosclerosis
- Interventions
- Other: ConsultationOther: Follow up at GPOther: Visualization of CTA images
- Registration Number
- NCT06413641
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 273
- New diagnosis of nonobstructive coronary artery disease
- No known coronary artery disease (no previous coronary revascularization)
- CAD-Rads score 1-3
- LDL cholesterol > 2.0 mmol/l
- Life expectancy >3 years
- Signed informed consent
- 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)
- BMI >40
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low intensity intervention Consultation Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test High intensity intervention Consultation 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 Usual care Follow up at GP Usual care follow up in general practice High intensity intervention Visualization of CTA images 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
- Primary Outcome Measures
Name Time Method Change in LDL cholesterol 12 months Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up
- Secondary Outcome Measures
Name Time Method Change in Body Mass Index 12 months Assessed at 12 months follow-up. Unit of measure kg/m2
Side effects of statin therapy 12 months Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up
Changes in high risk coronary plaque volumes 12 months Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary computed tomography angiography exam
Proportion of patients adherent to statin (%) 12 months Assessed with questionnaire at 12 months follow-up
Change in high-sensitive CRP 12 months Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up
Change in HbA1c 12 months Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up
Change in total-cholesterol levels 12 months Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up
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 Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months
Change in dietary, exercise, and smoking habits 12 months Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up
Change in Angina and Quality of Life-scores 12 months Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up
Adverse clinical events (%) 12 months Assessed by electronic patient records
Change in blood pressure 12 months Unit of measure: mmHg. Assessed at 12 months follow-up
Use of cardiovascular medication 12 months Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up
Trial Locations
- Locations (5)
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Bjarne L Nørgaard
🇩🇰Aarhus, Denmark
Hospital of South West Jutland
🇩🇰Esbjerg, Denmark
Vejle Hospital
🇩🇰Vejle, Denmark
Gødstrup Hospital
🇩🇰Gødstrup, Jutland, Denmark