Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
ID: NCT06960902
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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.
Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).
Treatment Arms Description
Visit 1: Inclusion Visit: Verification of eligibility criteria. Consent form signing, collection of clinical information, and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). POpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Visit 2 (30 months): Collection of the CAC score result (dated less than 6 months prior). Collection of clinical information and completion of questionnaires. Fasting blood draw for biological analyses and biobanking. Collection of urine and stool samples (optional). pOpmeter (optional), Fibroscan (optional), completion of the CONSTANCES and SF36 questionnaires. Major cardiovascular events will be collected from patients during telephone calls at 1 and 2 years, and during the 30-month visit.
- 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 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
- 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 Measures
- Presence of subclinical coronary atherosclerosis — Time Frame: At the time of performing the coronary CT scan
The criterion defining the presence of subclinical coronary atherosclerosis is the presence of at least one coronary stenosis greater than 50% in a main artery on coronary CT angiography
View Secondary Outcome Measures (31)
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
The biological data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
Arterial Doppler ultrasound of the carotid arteries and lower limbs as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
Pulse wave velocity measured by the pOpmeter as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
Hepatic steatosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
Hepatic fibrosis as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). — Time Frame: 30 months
Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study.
This trial is recruiting at 9 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 9 Facilities & Contact Sites
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View Official Medical/Scientific Title
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia