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Active, Not Recruiting

NCT Number: NCT06413641

VIsualization of Coronary Artery Disease for Modification of RISK Factors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Dyslipidemias Heart Diseases Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Non-Obstructive Coronary Atherosclerosis Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gødstrup Hospital, Gødstrup, Jutland, Denmark

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About this study

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.

A control group comprising 400 patients with non-obstructive coronary artery disease, stratified based on age, gender, symptoms, and Agatston score, will be identified in the Western Denmark Heart Registry for comparisons with the study groups to assess the influence of study participation on changes in low-density lipoprotein cholesterol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New diagnosis of nonobstructive coronary artery disease
  • No known coronary artery disease (no previous coronary revascularization)
  • Coronary Artery Disease Reporting and Data System (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

Treatment and study plan

Follow up at general practice

Other

As described before

consultation

Other

As described before

Visualization of CTA images

Other

As described before

Primary outcomes

  1. Change in LDL cholesterol

    Time frame: 12 months

    Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up

Secondary outcomes

  1. Side effects of statin therapy

    Time frame: 12 months

    Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up

  2. Changes in high risk coronary plaque volumes

    Time frame: 12 months

    Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary computed tomography angiography exam

  3. Proportion of patients adherent to statin (%)

    Time frame: 12 months

    Assessed with questionnaire at 12 months follow-up

  4. Change in high-sensitive C-reactive Protein

    Time frame: 12 months

    Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up

  5. Change in HbA1c

    Time frame: 12 months

    Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up

  6. Change in total-cholesterol levels

    Time frame: 12 months

    Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up

  7. Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level)

    Time frame: 12 months

    Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months

  8. Change in dietary, exercise, and smoking habits

    Time frame: 12 months

    Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up

  9. Change in Angina and Quality of Life-scores

    Time frame: 12 months

    Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up

  10. Adverse clinical events (%)

    Time frame: 12 months

    Assessed by electronic patient records

  11. Change in blood pressure

    Time frame: 12 months

    Unit of measure: mmHg. Assessed at 12 months follow-up

  12. Change in Body Mass Index

    Time frame: 12 months

    Assessed at 12 months follow-up. Unit of measure kg/m2

  13. Use of cardiovascular medication

    Time frame: 12 months

    Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Aalborg University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Gødstrup Hospital
  • Vejle Hospital

Registry information

Official study title

VIsualization of Coronary Artery Disease for Modification of RISK Factors. Prevention of Disease Progression in Patients With Non-Obstructive Coronary Atherosclerosis.

Acronym: VICAD-RISK

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 14, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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