VIsualization of Coronary Artery Disease for Modification of RISK Factors

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Non-Obstructive Coronary Atherosclerosis

• 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.

Study Timeline

• Study Start: 2024-03-12
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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
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
Change in Body Mass Index	12 months	Assessed at 12 months follow-up. Unit of measure kg/m2

Trial Locations

Locations (5)

Gødstrup Hospital; 🇩🇰 Gødstrup, Jutland, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Bjarne L Nørgaard; 🇩🇰 Aarhus, Denmark

Hospital of South West Jutland; 🇩🇰 Esbjerg, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark