Status:
RECRUITING
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
France 2030 program
European Union Next Generation
Conditions:
Familial Hypercholesterolemias
Atherosclerotic Cardiovascular Disease (ASCVD)
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The goal of this study (interventional clinical research not involving a health product) is to assess the prevalence of subclinical coronary atherosclerosis diagnosed by coronary CT angiography in hea...
Eligibility Criteria
Inclusion
- Person willing to sign the study consent form
- Person affiliated with a current social security scheme
- Person with a definite diagnosis of Familial Hypercholesterolemia, defined by a Dutch Lipid Clinic Network (DLCN) clinical-biological score \> 8 and/or an identified causal mutation in the LDL receptor (LDLR) gene, apolipoprotein B100 gene, PCSK9 gene, or apolipoprotein E gene
- Male aged 40 years or older, or female aged 50 years or older
- Ability to understand French for questionnaire completion
- Person not taking any lipid-lowering medication or on a stable dose of lipid-lowering therapy for at least one month prior to inclusion (three months for PCSK9 inhibitors) at Visit 1
- Person not taking any antihypertensive medication or on a stable dose of antihypertensive therapy for at least one month at Visit 1
- Person not taking any antidiabetic medication or on a stable dose of antidiabetic therapy for at least 3 months at Visit 1
Exclusion
- Subject with a technical contraindication for coronary CT scan: patient diameter \> 70 cm and/or weight \> 250 kg
- Patient with a history of atherosclerotic cardiovascular event (myocardial infarction, ischemic heart disease, coronary revascularization, ischemic stroke, carotid endarterectomy, lower limb arterial revascularization)
- Patient allergic to iodinated contrast agents
- Severe renal insufficiency: estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula ≤ 30 ml/min
- Subject with active cancer or in remission for less than 3 years
- Subject who has received oral or intravenous corticosteroid therapy within the last 6 months
- Subject with untreated or poorly controlled hypothyroidism
- Subject receiving immunosuppressive or anticancer therapy
- Subject refusing to participate
- Subject under guardianship, curatorship, or judicial protection, or without social insurance coverage
- Pregnant woman
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06960902
Start Date
September 25 2025
End Date
September 25 2029
Last Update
October 3 2025
Active Locations (9)
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1
CHU Dijon Bourgogne
Dijon, France
2
CHRU Lille
Lille, France
3
Hospices Civils de Lyon
Lyon, France
4
Hôpital de la Conception, AP-HM
Marseille, France