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

Official title

Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia

Overview

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.

Interventions

• Other 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).

Primary outcome measures

• Presence of subclinical coronary atherosclerosis [Time frame: At the time of performing the coronary CT scan]

Secondary outcome measures (12)

• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]
• Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [Time frame: 30 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 9 centers

• CHU Dijon Bourgogne — Dijon
• CHRU Lille — Lille
• Hospices Civils de Lyon — Lyon
• Hôpital de la Conception, AP-HM — Marseille
• CHU Nantes — Nantes
• Hôpital de la Pitié-Salpêtrière, AP-HP — Paris
• Hôpital Saint-Antoine, AP-HP — Paris
• CHU Rennes — Rennes
• … and 1 more center

Identifiers

NCT: NCT06960902 · RC24_0343 · 2025-A00453-46

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗