Clinical trial NCT06413641: VIsualization of Coronary Artery Disease for Modification of RISK Factors
Official title: VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Non-Obstructive Coronary Atherosclerosis
Keywords: Coronary computed tomography
Hypercholesterolemia
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Vejle Hospital
name: Gødstrup Hospital
name: Aalborg University Hospital
First posted: 2024-05-14
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change in LDL cholesterol
timeFrame: 12 months
Secondary outcomes:
measure: Side effects of statin therapy
timeFrame: 12 months
measure: Changes in high risk coronary plaque volumes
timeFrame: 12 months
measure: Proportion of patients adherent to statin (%)
timeFrame: 12 months
measure: Change in high-sensitive CRP
timeFrame: 12 months
measure: Change in HbA1c
timeFrame: 12 months
measure: Change in total-cholesterol levels
timeFrame: 12 months
measure: Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level)
timeFrame: 12 months
measure: Change in dietary, exercise, and smoking habits
timeFrame: 12 months
measure: Change in Angina and Quality of Life-scores
timeFrame: 12 months
measure: Adverse clinical events (%)
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: 12 months
measure: Change in Body Mass Index
timeFrame: 12 months
measure: Use of cardiovascular medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Gødstrup
country: Denmark
facility: Gødstrup Hospital
state: Jutland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Bjarne L Nørgaard
city: Esbjerg
country: Denmark
facility: Hospital of South West Jutland
city: Vejle
country: Denmark
facility: Vejle Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Bjarne L Nørgaard
role: PRINCIPAL_INVESTIGATOR
References: