Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Study Overview
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Brief Summary
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This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.

Official Title
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Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

Conditions
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Familial Hypercholesterolemia

Intervention / Treatment
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* Diagnostic Test: Coronary computed tomography angiography (CCTA)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with familial hypercholesterolemia, early treated<br> | Diagnostic Test: Coronary computed tomography angiography (CCTA)<br>* Participants undergo coronary computed tomography angiography (CCTA)<br>|
| Other: Patients without familial hypercholesterolemia, late treated<br> | Diagnostic Test: Coronary computed tomography angiography (CCTA)<br>* Participants undergo coronary computed tomography angiography (CCTA)<br>|
| Other: Healthy individuals<br> | Diagnostic Test: Coronary computed tomography angiography (CCTA)<br>* Participants undergo coronary computed tomography angiography (CCTA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total coronary plaque volume (mm3) |  | Day 0 | 
| Total coronary plaque burden (%) |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of >50% obstructive stenosis per vessel |  | Day 0 | 
| Presence of <50% nonobstructive stenosis per vessel |  | Day 0 | 
| 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 | 
| Low attenuation plaque burden (%) |  | 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 |