VIsualization of Coronary Artery Disease for Modification of RISK Factors

NCT06413641 | Active Not Recruiting DMC

• 2 other identifiers: NNF21OC00682001-10-72-213-22
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Artery Disease; Non-Obstructive Coronary Atherosclerosis

Keywords

Coronary computed tomography; Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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 C-reactive Protein

  12 months

• Change in HbA1c

  12 months

Study Arms (3)

Usual care

ACTIVE COMPARATOR

Usual care follow up in general practice

Other: Follow up at general practice

Low intensity intervention

EXPERIMENTAL

Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test

Other: Consultation

High intensity intervention

EXPERIMENTAL

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; Other: Visualization of CTA images

Interventions

Consultation OTHER

As described before

High intensity intervention; Low intensity intervention

Visualization of CTA images OTHER

As described before

High intensity intervention

Follow up at general practice OTHER

As described before

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Vejle Hospital: collaborator
• Gødstrup Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (5)

Gødstrup Hospital

Gødstrup, Jutland, Denmark

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Bjarne L Nørgaard

Aarhus, Denmark

Location

Hospital of South West Jutland

Esbjerg, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40187715 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Hypercholesterolemia

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Bjarne L Nørgaard

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, DMSCi, PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: May 14, 2024
• Study Start: March 12, 2024
• Primary Completion: May 15, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)