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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
273
Gødstrup Hospital
Gødstrup, Jutland, Denmark
RECRUITINGAalborg University Hospital
Aalborg, Denmark
RECRUITINGBjarne L Nørgaard
Aarhus, Denmark
RECRUITINGChange 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 CRP
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)
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Hospital of South West Jutland
Esbjerg, Denmark
RECRUITINGVejle Hospital
Vejle, Denmark
RECRUITINGAssessed 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