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VIsualization of Coronary Artery Disease for Modification of RISK Factors

VIsualization of Coronary Artery Disease for Modification of RISK Factors

Recruiting
18 years and older
All
Phase N/A

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Overview

The VICAD-RISK study assesses if visualization of coronary CT angiography 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.

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 390 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

Inclusion Criteria:

  • Symptoms suggestive of chronic coronary syndrome
  • No known CAD (no previous coronary revascularization)
  • CAD-Rads score 1-3
  • Sinus rhythm
  • LDL cholesterol > 2.0 mM
  • Life expectancy >3 years
  • Signed informed consent

Exclusion Criteria:

  • Post CTA test indication for invasive coronary angiography
  • Nonevaluable 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 programme
  • Pregnancy

Study details
    Coronary Artery Disease
    Non-Obstructive Coronary Atherosclerosis

NCT06413641

Aarhus University Hospital

20 May 2024

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