## Protocol Section
### Identification Module
**NCT ID:** NCT06413641

**Acronym:** VICAD-RISK

**Brief Title:** VIsualization of Coronary Artery Disease for Modification of RISK Factors

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

#### Organization Study ID Info
**ID:** NNF21OC0068200
#### Organization
**Class:** OTHER
**Full Name:** Aarhus University Hospital
#### Secondary ID Infos
**Domain:** VMK NVK
**ID:** 1-10-72-213-22
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-12
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hospital of South West Jutland

**Class:** OTHER

**Name:** Vejle Hospital

**Class:** OTHER

**Name:** Gødstrup Hospital

**Class:** OTHER

**Name:** Aalborg University Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Aarhus University Hospital

#### Responsible Party

**Investigator Affiliation:** Aarhus University Hospital

**Investigator Full Name:** Bjarne Linde Nørgaard

**Investigator Title:** MD, Professor, DMSCi, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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 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.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

- Non-Obstructive Coronary Atherosclerosis

**Keywords:**

- Coronary computed tomography

- Hypercholesterolemia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 390

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Usual care follow up in general practice

**Intervention Names:**

- Other: Follow up at GP

**Label:** Usual care

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Individualized video-based or ambulatory consultation by a special trained nurse within 2 weeks from the index CTA test

**Intervention Names:**

- Other: Consultation

**Label:** Low intensity intervention

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** 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

**Intervention Names:**

- Other: Consultation

- Other: Visualization of CTA images

**Label:** High intensity intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Usual care

**Description:** As described before

**Name:** Follow up at GP

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- High intensity intervention

- Low intensity intervention

**Description:** As described before

**Name:** Consultation

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- High intensity intervention

**Description:** As described before

**Name:** Visualization of CTA images

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Assessed by measurement of LDL cholesterol level (mmol/L) in blood samples at baseline and 12 months follow-up

**Measure:** Change in LDL cholesterol

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Assessed with questionnaire (based on numeric pain rating scale) at 3 and 12 months follow-up

**Measure:** Side effects of statin therapy

**Time Frame:** 12 months

**Description:** Assessed by changes in the CT-derived coronary plaque burden from the baseline to a 12 months coronary CTA exam

**Measure:** Changes in high risk coronary plaque volumes

**Time Frame:** 12 months

**Description:** Assessed with questionnaire at 12 months follow-up

**Measure:** Proportion of patients adherent to statin (%)

**Time Frame:** 12 months

**Description:** Assessed by measurement of high-sensitive CRP level (mg/L) in blood samples at baseline and 12 months follow-up

**Measure:** Change in high-sensitive CRP

**Time Frame:** 12 months

**Description:** Assessed by measurement of HbA1c (mmol/mol) in blood samples at baseline and 12 months follow-up

**Measure:** Change in HbA1c

**Time Frame:** 12 months

**Description:** Assessed by measurement of total cholesterol levels (mmol/L) blood samples at baseline and 12 months follow-up

**Measure:** Change in total-cholesterol levels

**Time Frame:** 12 months

**Description:** Assessed with blood samples at baseline and 12 months follow-up, and preferably at 3 months

**Measure:** Proportion of patients in whom target LDL was reached (<1.8 mmol/L and ≤ 50% reduction relative to the non-treated LDL level)

**Time Frame:** 12 months

**Description:** Assessed with questionnaire (based on national questionnaire every fourth year: "How are you?" (Hvordan har du det?)) at 12 months follow-up

**Measure:** Change in dietary, exercise, and smoking habits

**Time Frame:** 12 months

**Description:** Assessed with questionnaire (based on HeartQoL and SAQ7) at baseline and12 months follow-up

**Measure:** Change in Angina and QoL scores

**Time Frame:** 12 months

**Description:** Assessed by electronic patient records

**Measure:** Adverse clinical events (%)

**Time Frame:** 12 months

**Description:** Unit of measure: mmHg. Assessed at 12 months follow-up

**Measure:** Change in blood pressure

**Time Frame:** 12 months

**Description:** Assessed at 12 months follow-up. Unit of measure kg/m2

**Measure:** Change in BMI

**Time Frame:** 12 months

**Description:** Assessed by Electronic patient records and Shared Medication Record at 12 months follow-up

**Measure:** Use of cardiovascular medication

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bjarnoer@rm.dk

**Name:** Bjarne L Nørgaard

**Phone:** 004540136570

**Role:** CONTACT

**Contact 2:**

**Email:** arckul@uni.au.dk

**Name:** Archana Kulasingam

**Phone:** 004529296612

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aarhus

**Contacts:**

***Contact 1:***

- **Email:** bjarnoer@rm.dk

- **Name:** Bjarne L Nørgaard

- **Role:** CONTACT

***Contact 2:***

- **Name:** Archana Kulasingam, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Bjarne L Nørgaard

**Status:** RECRUITING

**Location 2:**

**City:** Esbjerg

**Contacts:**

***Contact 1:***

- **Name:** Niels PR Sand

- **Role:** CONTACT

***Contact 2:***

- **Name:** Niels PR Sand, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Hospital of South West Jutland

**Status:** NOT_YET_RECRUITING

**Location 3:**

**City:** Vejle

**Contacts:**

***Contact 1:***

- **Name:** Martin Busk

- **Role:** CONTACT

***Contact 2:***

- **Name:** Martin Busk, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Vejle Hospital

**Status:** NOT_YET_RECRUITING

**Zip:** 7100

#### Overall Officials

**Official 1:**

**Affiliation:** Aarhus University Hospital

**Name:** Bjarne L Nørgaard

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M26188

- Name: Atherosclerosis

- Relevance: HIGH

- As Found: Atherosclerosis

- ID: M9988

- Name: Hypercholesterolemia

- Relevance: LOW

- As Found: Unknown

- ID: M20559

- Name: Disease Progression

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

- ID: D000050197

- Term: Atherosclerosis

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
