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Coronary Artery DiseaseVICAD-RISKNCT06413641

VIsualization of Coronary Artery Disease for Modification of RISK Factors

A study testing Follow up at general practice, Consultation and Visualization of CTA images in people with Coronary Artery Disease and Non-Obstructive Coronary Atherosclerosis, run by Aarhus University Hospital at 5 sites in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Follow up at general practice, Consultation and Visualization of CTA images
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
5 sitesDenmark
Study dates
12 Mar 2024to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Denmark5 sites

  • Aalborg University Hospital

    Aalborg

  • Bjarne L Nørgaard

    Aarhus

  • Hospital of South West Jutland

    Esbjerg

  • Gødstrup Hospital

    Gødstrup, Jutland

  • Vejle Hospital

    Vejle, 7100

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Being tested
Follow up at general practice, Consultation, Visualization of CTA images
Keywords
Coronary computed tomography, Hypercholesterolemia
Medical subject headings
Coronary Artery Disease, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follow up at general practiceOther

    As described before

  • ConsultationOther

    As described before

  • Visualization of CTA imagesOther

    As described before

Study groups in NCT06413641
Study groupRoleWhat they receive
Usual careActive comparatorUsual care follow up in general practice
Receives: Other: Follow up at general practice
Low intensity interventionExperimentalIndividualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test
Receives: Other: Consultation
High intensity interventionExperimentalIndividualized 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
Receives: Other: Consultation; Other: Visualization of CTA images

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LDL cholesterol

    Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up

    Measured: 12 months

Secondary outcomes (13)

  1. Side effects of statin therapy

    Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. Proportion of patients adherent to statin (%)

    Assessed with questionnaire at 12 months follow-up

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. Change in HbA1c

    Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up

    Measured: 12 months

  6. Change in total-cholesterol levels

    Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. 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

    Measured: 12 months

  9. Change in Angina and Quality of Life-scores

    Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up

    Measured: 12 months

  10. Adverse clinical events (%)

    Assessed by electronic patient records

    Measured: 12 months

  11. Change in blood pressure

    Unit of measure: mmHg. Assessed at 12 months follow-up

    Measured: 12 months

  12. Change in Body Mass Index

    Assessed at 12 months follow-up. Unit of measure kg/m2

    Measured: 12 months

  13. Use of cardiovascular medication

    Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2024
  2. Study start12 Mar 2024
  3. Primary completion15 May 2025
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized 1:1:1 to post-CTA usual care follow up in general practice or one of two intervention strategies ("low" or "high" intensity intervention). Patients randomized to the intervention groups will be invited to an individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test.
Masking
None (open label)
Enrolment
273 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06413641
Sponsor's protocol ID
NNF21OC0068200
Other IDs
1-10-72-213-22
Acronym
VICAD-RISK
Status last verified
May 2026
First submitted
12 Apr 2024
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40187715

Questions about this trial

What is this clinical trial studying?

A study testing Follow up at general practice, Consultation and Visualization of CTA images in people with Coronary Artery Disease and Non-Obstructive Coronary Atherosclerosis, run by Aarhus University Hospital at 5 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LDL cholesterol (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06413641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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