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NCT06413641 | RECRUITING | Coronary Artery Disease

VIsualization of Coronary Artery Disease for Modification of RISK Factors
Sponsor:

Aarhus University Hospital

Information provided by (Responsible Party):

Bjarne Linde Nørgaard

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.

Condition or disease

Coronary Artery Disease

Non-Obstructive Coronary Atherosclerosis

Intervention/treatment

Follow up at general practice

Consultation

Visualization of CTA images

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 273 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.
Actual Study Start Date : 2024-03-12
Estimated Primary Completion Date : 2025-08-31
Estimated Study Completion Date : 2026-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
VIsualization of Coronary Artery Disease for Modification of RISK Factors

Location Details

NCT06413641

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Denmark, Jutland

Gødstrup Hospital

Gødstrup, Jutland, Denmark,

RECRUITING

Denmark,

Aalborg University Hospital

Aalborg, Denmark,

RECRUITING

Denmark,

Bjarne L Nørgaard

Aarhus, Denmark,

RECRUITING

Denmark,

Hospital of South West Jutland

Esbjerg, Denmark,

RECRUITING

Denmark,

Vejle Hospital

Vejle, Denmark, 7100