Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1-10-72-213-22 | Other Identifier | VMK NVK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Vejle Hospital | OTHER |
| Gødstrup Hospital | OTHER |
| Aalborg University Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care follow up in general practice |
|
| Low intensity intervention | Experimental | Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test |
|
| High intensity intervention | Experimental | Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test combined with visualization of the individual CTA images with focus on the atherosclerotic findings and the effect of statin treatment on the disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow up at general practice | Other | As described before |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of statin therapy | Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bjarne L Nørgaard | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gødstrup Hospital | Gødstrup | Jutland | Denmark | |||
| Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40187715 | Derived | Kulasingam A, Laustsen S, Busk M, Sand NR, Winther S, Kragholm K, Hammid O, Pedersen KB, Vedsted P, Kanstrup H, Mortensen MB, Grove EL, Jensen JM, Norgaard BL. Rationale and design of VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors. Am Heart J. 2025 Sep;287:16-23. doi: 10.1016/j.ahj.2025.04.002. Epub 2025 Apr 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2024 | May 4, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
Not provided
Not provided
| OTHER |
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.
Not provided
Not provided
Not provided
Not provided
| Consultation |
| Other |
As described before |
|
| Visualization of CTA images | Other | As described before |
|
| 12 months |
| Proportion of patients adherent to statin (%) | Assessed with questionnaire at 12 months follow-up | 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 | 12 months |
| Change in HbA1c | Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up | 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 | 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) | Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months | 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 | 12 months |
| Change in Angina and Quality of Life-scores | Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up | 12 months |
| Adverse clinical events (%) | Assessed by electronic patient records | 12 months |
| Change in blood pressure | Unit of measure: mmHg. Assessed at 12 months follow-up | 12 months |
| Change in Body Mass Index | Assessed at 12 months follow-up. Unit of measure kg/m2 | 12 months |
| Use of cardiovascular medication | Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up | 12 months |
| Aalborg |
| Denmark |
| Bjarne L Nørgaard | Aarhus | Denmark |
| Hospital of South West Jutland | Esbjerg | Denmark |
| Vejle Hospital | Vejle | 7100 | Denmark |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |