Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
| Registry | NCT06960902, acronym ATHERO-FH |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 600 (Estimated) |
| Sponsor | Nantes University Hospital (Other); collaborators: France 2030 program, European Union |
| Conditions | Familial Hypercholesterolemias, Atherosclerotic Cardiovascular Disease (ASCVD) |
| Interventions | Coronary CT scan with CAC score measurement (Other) |
| Dates | start 2025-09-25, primary completion 2027-03-25 (estimated), completion 2029-09-25 (estimated), first posted 2025-05-07, last updated 2026-03-19 |
| Locations | 9 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Familial Hypercholesterolemias All trials for Atherosclerotic Cardiovascular Disease (ASCVD) All trials of Coronary CT scan with CAC score measurement
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Single arm | Other | Other: Coronary CT scan with CAC score measurement | 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. |
- Coronary CT scan with CAC score measurement (Other): Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).
+Outcome measures
Primary outcomes
- Presence of subclinical coronary atherosclerosis [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
Secondary outcomes
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). [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). [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). [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). [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). [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). [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). [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). [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). [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). [30 months]: Nutritional data 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). [30 months]: Physical activity 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). [30 months]: Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [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 a coronary calcium score less than or equal to the 25th percentile [30 months]: Nutritional data as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile [30 months]: Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile [30 months]: Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.
- Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months. [30 months]: Semi-quantitative visual quantification of coronary stenoses on CT coronary angiography according to the CAD-RADS v2.0 classification and visual characterization of high-risk plaque features (vulnerability).
- Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months. [30 months]: Quantification of total coronary atherosclerotic plaque, calcified and non-calcified, and by artery
- Study of the association between the presence of subclinical atherosclerosis (coronary stenosis > 50% on CT coronary angiography) and major cardiovascular events at 30 months [30 months]: Assess the association between the presence of significant coronary stenosis (>50% on a major artery) on coronary CT and the following major cardiovascular events:
* Acute coronary syndrome or myocardial infarction
* Coronary revascularization: angioplasty or bypass
* Ischemic stroke
* Carotid endarterectomy
* Revascularization of a lower limb artery: angioplasty or bypass
* Amputation related to PAD
* Cardiovascular death
- Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months [30 months]: Assess the occurrence of major cardiovascular events and mortality according to the percentile of the coronary calcium score.
- Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months. [30 months]: Assess the occurrence of major cardiovascular events and mortality according to the measurement of arterial stiffness evaluated by pulse wave velocity measured with the pOpmeter
- Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months [30 months]: Evaluer la survenue des événements cardiovasculaires majeurs et la mortalité en fonction de la stéatose hépatique
- Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months [30 months]: Assess the occurrence of major cardiovascular events and mortality according to the presence of liver fibrosis
+Eligibility
Sex: All, ages: 40 Years to any
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
+Locations (9)
| Facility | City | Country | Status |
|---|
| 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 |