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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
273
Gødstrup Hospital
Gødstrup, Jutland, Denmark
Aalborg University Hospital
Aalborg, Denmark
Bjarne L Nørgaard
Aarhus, Denmark
Hospital of South West Jutland
Esbjerg, Denmark
Vejle Hospital
Change in LDL cholesterol
Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up
Time frame: 12 months
Side effects of statin therapy
Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up
Time frame: 12 months
Changes in high risk coronary plaque volumes
Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary computed tomography angiography exam
Time frame: 12 months
Proportion of patients adherent to statin (%)
Assessed with questionnaire at 12 months follow-up
Time frame: 12 months
Change in high-sensitive C-reactive Protein
Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up
Time frame: 12 months
Change in HbA1c
Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up
Time frame: 12 months
Change in total-cholesterol levels
Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up
Time frame: 12 months
Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vejle, Denmark
Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months
Time frame: 12 months
Change in dietary, exercise, and smoking habits
Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up
Time frame: 12 months
Change in Angina and Quality of Life-scores
Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up
Time frame: 12 months
Adverse clinical events (%)
Assessed by electronic patient records
Time frame: 12 months
Change in blood pressure
Unit of measure: mmHg. Assessed at 12 months follow-up
Time frame: 12 months
Change in Body Mass Index
Assessed at 12 months follow-up. Unit of measure kg/m2
Time frame: 12 months
Use of cardiovascular medication
Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up
Time frame: 12 months