Familial Hypercholesterolemia
Conditions
Brief summary
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.
Interventions
DIAGNOSTIC_TESTCoronary computed tomography angiography (CCTA)
Participants undergo coronary computed tomography angiography (CCTA)
Sponsors
Dutch Heart Foundation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total coronary plaque volume (mm3) | Day 0 |
| Total coronary plaque burden (%) | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| Calcified coronary plaque volume (mm^3) | Day 0 |
| Calcified coronary plaque burden (%) | Day 0 |
| Non-calcified plaque volume (mm^3) | Day 0 |
| Non-calcified plaque burden (%) | Day 0 |
| Low attenuation plaque volume (mm^3) | Day 0 |
| Presence of >50% obstructive stenosis per vessel | Day 0 |
| Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign) | Day 0 |
| Pericoronary adipose tissue attenuation (Hounsfield units) | Day 0 |
| Plasma LDL cholesterol (mmol/l) | Day 0 |
| Plasma apolipoprotein B (g/l) | Day 0 |
| Low attenuation plaque burden (%) | Day 0 |
| Presence of <50% nonobstructive stenosis per vessel | Day 0 |
Countries
Netherlands
Outcome results
None listed