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Clinical Trials in France / NCT06960902
Recruiting Not applicable

Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)

NCT06960902 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-09-25
Last updated
2026-03-19

Condition(s) studied

Familial HypercholesterolemiasAtherosclerotic Cardiovascular Disease (ASCVD)

Investigational drug(s) / intervention(s)

Coronary CT scan with CAC score measurement

Coronary CT scan with CAC score measurement: Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).

Study 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 heart failure patients in primary prevention, across different levels of cardiovascular risk defined by coronary artery calcium (CAC) score percentiles (based on data from the MESA study): low risk (≤25th percentile for age, sex, and ethnicity), intermediate risk (25th \< CAC ≤ 75th percentile), and high risk (\>75th percentile). The Patients will attend an on-site visit at inclusion (and must undergo a coronary CT angiography within 6 months following this visit), will be contacted by phone at 1 year and 2 years, and will return for an on-site visit at 30 months.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
CHU Dijon Bourgogne Dijon France Recruiting
CHRU Lille Lille France Not Yet Recruiting
Hospices Civils de Lyon Lyon France Recruiting
Hôpital de la Conception, AP-HM Marseille France Not Yet Recruiting
CHU Nantes Nantes France Recruiting
Hôpital de la Pitié-Salpêtrière, AP-HP Paris France Recruiting
Hôpital Saint-Antoine, AP-HP Paris France Recruiting
CHU Rennes Rennes France Recruiting
CHU Strasbourg Strasbourg France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960902 on ClinicalTrials.gov ↗ ← All trials in France