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

Aarhus University Hospital

Status: Enrolling

Conditions: Coronary Artery Disease; Non-Obstructive Coronary Atherosclerosis

Treatments: Other: Visualization of CTA images; Other: Follow up at general practice; Other: Consultation

Study type: Interventional

Funder types: Other

Identifiers

NCT06413641

NNF21OC0068200

1-10-72-213-22 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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273 participants in 3 patient groups

Usual care

Active Comparator group

Description:

Usual care follow up in general practice

Treatment:

Other: Follow up at general practice

Low intensity intervention

Experimental group

Description:

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

Treatment:

Other: Consultation

High intensity intervention

Experimental group

Description:

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

Treatment:

Other: Consultation

Other: Visualization of CTA images