Proteomics and genomics combined with CT to predict CVD

Recruiting

Conditions: atherosclerosis
10011082

Registration Number: NL-OMON53785

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

- Adult subjects between 50 and 75 years old.
- Subjects at intermediate to high risk for ASCVD
- Asymptomatic subjects without cardiac chest pain
- Evidence of atherosclerosis on baseline CCTA

Exclusion Criteria

- Renal insufficiency, defined as eGFR < 30 ml/min
- History of cardiovascular events (myocardial infarction, peripheral artery
disease and ischemic stroke)
- Use of lipid lowering therapy other than statin, ezetimibe or bempedoic acid
monotherapy
- Change in lipid lowering therapy in the last 6 months
- Use of more than two antihypertensive agents
- No coronary atherosclerosis at baseline imaging
- Active malignancy requiring treatment
- Atrial fibrillation
- Any other treatment or clinically relevant condition that could interfere
with the conduct or interpretation of the study in the opinion of the
investigator
- Inability or unwillingness to comply with the protocol requirements, or
deemed by investigator to be unfit for the study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter to study will be the total coronary plaque volume<br /><br>progression.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Presence of obstructive stenosis (and number of vessels)<br /><br>• Progression in number of significant (>50%) and severe (>70%) stenoses<br /><br>• Absolute total plaque volume progression (mm3)<br /><br>• Calcified plaque volume progression (mm3)<br /><br>• Non-calcified plaque volume progression (mm3)<br /><br>• Low-attenuation plaque volume progression (mm3)<br /><br>• Change in Pericoronary Adipose Tissue CT-Attenuation (HU)<br /><br>• CAD-RADS progression (yes/no)<br /><br>• Progression in number of high-risk plaque characteristics (yes/no).</p><br>