Determinants of coronary atherosclerosis in familial hypercholesterolemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses coronary CT angiography, including coronary artery calcium (CAC) scoring, to detect subclinical coronary atherosclerosis in people with familial hypercholesterolemia who have not had clinical cardiovascular events. Participants attend an on-site inclusion visit and must undergo coronary CT angiography within six months, with phone follow-ups at one and two years and a return on-site visit at 30 months. CAC scores will be referenced to age-, sex-, and ethnicity-specific percentiles from the MESA study to define low, intermediate, and high risk groups. The approach measures how common hidden plaque is across those risk strata to inform prevention strategies.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Dijon Bourgogne
  Dijon, France Recruiting
• Hospices Civils de Lyon
  Lyon, France 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

Study contacts

• Study coordinator: Bertrand CARIOU, Pr
• Email: bertrand.cariou@chu-nantes.fr
• Phone: +33 2 53 48 27 10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.