VIsualization of Coronary Artery Disease for Modification of RISK Factors

Coronary Artery Disease Clinical Trial

— VICAD-RISK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413641
• Other study ID #: NNF21OC0068200
• Secondary ID: 1-10-72-213-22
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: Aarhus University Hospital
• Contact: Bjarne L Nørgaard
• Phone: 004540136570
• Email: bjarnoer[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The VICAD-RISK study assesses if visualization of coronary CT angiography 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.

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 390 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 390
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms suggestive of chronic coronary syndrome

• No known CAD (no previous coronary revascularization)

• CAD-Rads score 1-3

• Sinus rhythm

• LDL cholesterol > 2.0 mM

• Life expectancy >3 years

• Signed informed consent

Exclusion Criteria:

• Post CTA test indication for invasive coronary angiography

• Nonevaluable 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 programme

• Pregnancy

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis

Intervention

Other:
• Follow up at GP
As described before
• Consultation
As described before
• Visualization of CTA images
As described before

Locations

Country	Name	City	State
Denmark	Bjarne L Nørgaard	Aarhus
Denmark	Hospital of South West Jutland	Esbjerg
Denmark	Vejle Hospital	Vejle

Sponsors (5)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aalborg University Hospital, Gødstrup Hospital, Hospital of South West Jutland, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL cholesterol	Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up	12 months
Secondary	Side effects of statin therapy	Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up	12 months
Secondary	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 CTA exam	12 months
Secondary	Proportion of patients adherent to statin (%)	Assessed with questionnaire at 12 months follow-up	12 months
Secondary	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	12 months
Secondary	Change in HbA1c	Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up	12 months
Secondary	Change in total-cholesterol levels	Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up	12 months
Secondary	Proportion of patients in whom target LDL was reached (<1.8 mmol/L and = 50% reduction relative to the non-treated LDL level)	Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months	12 months
Secondary	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	12 months
Secondary	Change in Angina and QoL scores	Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up	12 months
Secondary	Adverse clinical events (%)	Assessed by electronic patient records	12 months
Secondary	Change in blood pressure	Unit of measure: mmHg. Assessed at 12 months follow-up	12 months
Secondary	Change in BMI	Assessed at 12 months follow-up. Unit of measure kg/m2	12 months
Secondary	Use of cardiovascular medication	Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up	12 months