Plaque reversal with Early, Aggressive Lipid Lowering

Recruiting

Conditions: atherosclerosis
10011082
10003216

Registration Number: NL-OMON49626

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Diagnosed with heterozygous familial hypercholesterolemia
- Adult between 18 and 50 years old
- LDL cholesterol levels above 100 mg/dl (>2.6 mmol/L) at inclusion

Exclusion Criteria

- Renal insufficiency, defined as eGFR < 30 ml/min
- History of atherosclerotic cardiovascular events
- 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 mean plaque progression (absolute<br /><br>difference in total plaque volume between the initial and follow-up CCTA scan). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters to be studied will be the following:<br /><br>• Relative mean plaque progression<br /><br>• Number of high-risk plaque features, i.e.:<br /><br>o positive remodelling (RI>1.1)<br /><br>o low attenuation plaque (<= 30 HU)<br /><br>o spotty calcification<br /><br>o napkin ring sign<br /><br>• Difference in non-calcified plaque volume between baseline and follow-up CCTA<br /><br>(delta non-calcified plaque volume)<br /><br>• Difference in calcified plaque volume between baseline and follow-up CCTA<br /><br>(delta calcified plaque volume)<br /><br>• Difference in fat attenuation index (FAI) between initial and follow-up CCTA<br /><br>scan<br /><br>• Lipid parameters</p><br>