VIsualization of Coronary Artery Disease for Modification of RISK Factors (VICAD-RISK)

VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Non-Obstructive Coronary Atherosclerosis
• Intervention / Treatment: Other: Consultation; Other: Visualization of CTA images; Other: Follow up at general practice

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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Bjarne L Nørgaard
  • Esbjerg, Denmark
    • Hospital of South West Jutland
  • Vejle, Denmark, 7100
    • Vejle Hospital
  • Jutland
    • Gødstrup, Jutland, Denmark
      • Gødstrup Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Usual care follow up in general practice	Other: Follow up at general practice; As described before
Experimental: Low intensity intervention; Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test	Other: Consultation; As described before
Experimental: 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	Other: Consultation; As described before; Other: Visualization of CTA images; As described before

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL cholesterol	Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects of statin therapy	Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up	12 months
Proportion of patients adherent to statin (%)	Assessed with questionnaire at 12 months follow-up	12 months
Change in HbA1c	Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up	12 months
Change in total-cholesterol levels	Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up	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)	Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months	12 months
Change in dietary, exercise, and smoking habits	Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up	12 months
Adverse clinical events (%)	Assessed by electronic patient records	12 months
Change in blood pressure	Unit of measure: mmHg. Assessed at 12 months follow-up	12 months
Use of cardiovascular medication	Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up	12 months
Changes in high risk coronary plaque volumes	Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary computed tomography angiography exam	12 months
Change in Angina and Quality of Life-scores	Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up	12 months
Change in Body Mass Index	Assessed at 12 months follow-up. Unit of measure kg/m2	12 months
Change in high-sensitive C-reactive Protein	Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up	12 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Vejle Hospital; Aalborg University Hospital; Gødstrup Hospital; Esbjerg Hospital - University Hospital of Southern Denmark
• Investigators: Principal Investigator: Bjarne L Nørgaard, Aarhus University Hospital

Publications and helpful links

General Publications

• Kulasingam A, Laustsen S, Busk M, Sand NR, Winther S, Kragholm K, Hammid O, Pedersen KB, Vedsted P, Kanstrup H, Mortensen MB, Grove EL, Jensen JM, Norgaard BL. Rationale and design of VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors. Am Heart J. 2025 Sep;287:16-23. doi: 10.1016/j.ahj.2025.04.002. Epub 2025 Apr 3.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Hypercholesterolemia; Coronary computed tomography
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Nutritional and Metabolic Diseases; Hypercholesterolemia; Coronary Artery Disease; Professional Practice; Organization and Administration; Health Services Administration; Referral and Consultation
• Other Study ID Numbers: NNF21OC0068200; 1-10-72-213-22 (Other Identifier: VMK NVK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No