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NCT Number: NCT06960902

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

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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Key information

Conditions

Familial Hypercholesterolemias Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease (ASCVD) Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).

    Time frame: 30 months

    Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study.

  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

    Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.

  13. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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

  14. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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

  15. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  16. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  17. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  18. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  19. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  20. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  21. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  22. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    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.

  23. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    Time frame: 30 months

    Physical activity as part of the current study will be comparable to the data collected as part of the SAFIR study.

  24. Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile

    Time frame: 30 months

    Quality of life as part of the current study will be comparable to the data collected as part of the SAFIR study.

  25. Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months.

    Time frame: 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).

  26. Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months.

    Time frame: 30 months

    Quantification of total coronary atherosclerotic plaque, calcified and non-calcified, and by artery

  27. Study of the association between the presence of subclinical atherosclerosis (coronary stenosis > 50% on CT coronary angiography) and major cardiovascular events at 30 months

    Time frame: 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

  28. Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months

    Time frame: 30 months

    Assess the occurrence of major cardiovascular events and mortality according to the percentile of the coronary calcium score.

  29. Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months.

    Time frame: 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

  30. Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months

    Time frame: 30 months

    Evaluer la survenue des événements cardiovasculaires majeurs et la mortalité en fonction de la stéatose hépatique

  31. Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months

    Time frame: 30 months

    Assess the occurrence of major cardiovascular events and mortality according to the presence of liver fibrosis

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand CARIOU, Pr

CONTACT

[email protected]

+33 2 53 48 27 10

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • European Union
  • France 2030 program

Registry information

Official study title

Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia

Acronym: ATHERO-FH

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
May 7, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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