Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Completed

• Conditions: familial hypercholesterolemia; 10011082

• Registration Number: NL-OMON51451
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-19
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 135

Inclusion Criteria

- Diagnosed with heterozygous familial hypercholesterolemia or non-FH control
- Adult patients between 25 and 55 years old

Exclusion Criteria

- Renal insufficiency, defined as eGFR < 30 ml/min
- 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.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters to be studied will be the following:<br /><br>• Presence of obstructive stenosis (and number of vessels)<br /><br>• Presence of any stenosis (and number of vessels)<br /><br>• Calcified plaque volume<br /><br>• Non-calcified plaque volume<br /><br>• Number and presence 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>• Fat attenuation index (FAI)<br /><br>• Lipid parameters</p><br>