Coronary Artery Disease, Non-Obstructive Coronary Atherosclerosis
Conditions
Keywords
Coronary computed tomography, Hypercholesterolemia
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.
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. 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.
Interventions
OTHERFollow up at general practice
As described before
OTHERConsultation
As described before
OTHERVisualization of CTA images
As described before
Sponsors
Aarhus University Hospital
Esbjerg Hospital - University Hospital of Southern Denmark
Vejle Hospital
Gødstrup Hospital
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomized 1:1:1 to post-CTA usual care follow up in general practice or one of two intervention strategies ("low" or "high" intensity intervention). Patients randomized to the intervention groups will be invited to an individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL cholesterol | 12 months | Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects of statin therapy | 12 months | Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up |
| Changes in high risk coronary plaque volumes | 12 months | Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary computed tomography angiography exam |
| Proportion of patients adherent to statin (%) | 12 months | Assessed with questionnaire at 12 months follow-up |
| Change in high-sensitive C-reactive Protein | 12 months | Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up |
| Change in HbA1c | 12 months | Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up |
| Change in total-cholesterol levels | 12 months | Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up |
| Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level) | 12 months | Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months |
| Change in dietary, exercise, and smoking habits | 12 months | Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up |
| Change in Angina and Quality of Life-scores | 12 months | Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up |
| Adverse clinical events (%) | 12 months | Assessed by electronic patient records |
| Change in blood pressure | 12 months | Unit of measure: mmHg. Assessed at 12 months follow-up |
| Change in Body Mass Index | 12 months | Assessed at 12 months follow-up. Unit of measure kg/m2 |
| Use of cardiovascular medication | 12 months | Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORBjarne L Nørgaard
Aarhus University Hospital
Outcome results
None listed