Visualizing coronary artery disease to improve risk factor management
VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.
This study is testing if showing heart images to patients with non-blocked coronary artery disease can help them better manage their cholesterol levels and reduce side effects from their medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 273 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 5 sites (Gødstrup, Jutland and 4 other locations) |
| Trial ID | NCT06413641 on ClinicalTrials.gov |
What this trial studies
The VICAD-RISK study evaluates whether showing coronary CT angiography images to patients with non-obstructive coronary artery disease can enhance the management of LDL cholesterol levels and reduce side effects from cholesterol-lowering medications over a 12-month period. The study will involve 273 patients who will be randomized into three groups: standard follow-up, structured disease education, or a combination of both with image visualization. This approach aims to improve treatment adherence and modify the disease phenotype in patients who often struggle with risk factor management. A follow-up CT angiography will be conducted after one year to assess changes.
Who should consider this trial
Good fit: Ideal candidates are individuals newly diagnosed with non-obstructive coronary artery disease and elevated LDL cholesterol levels.
Not a fit: Patients with obstructive coronary artery disease or those currently undergoing lipid-lowering treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of cholesterol levels and reduced cardiovascular risks for patients with non-obstructive coronary artery disease.
How similar studies have performed: Other studies have shown that visual aids can enhance patient understanding and adherence to treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gødstrup, Jutland and 4 other locations
- Gødstrup Hospital — Gødstrup, Jutland, Denmark (Recruiting)
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Bjarne L Nørgaard — Aarhus, Denmark (Recruiting)
- Hospital of South West Jutland — Esbjerg, Denmark (Recruiting)
- Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Bjarne L Nørgaard — Aarhus University Hospital
- Study coordinator: Bjarne L Nørgaard
- Email: bjarnoer@rm.dk
- Phone: 004540136570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.