Actively Recruiting
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
Led by Nantes University Hospital · Updated on 2026-03-19
600
Participants Needed
9
Research Sites
130 weeks
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
F
France 2030 program
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the presence of hidden coronary artery disease in people with familial hypercholesterolemia who have not yet had heart problems. The study looks at how common this silent artery disease is across different levels of heart risk based on calcium scores in the arteries. The study uses coronary CT angiography to detect artery disease in participants and aims to understand factors linked to artery blockages and heart events in this group. Participants will attend an initial visit where eligibility is checked and consent is given. They will undergo various tests including a coronary CT scan within six months after this visit. After 30 months, participants return for another visit to collect updated clinical information, repeat blood tests, and questionnaires. Optional samples and tests like urine, stool, and special liver and artery stiffness assessments may also be done. Between visits, researchers will contact participants by phone at 1 and 2 years to monitor major heart events. During the study, participants will provide medical history and complete questionnaires. Blood samples will be taken for analysis and biobanking, and optional collections of urine and stool can be done. The main outcome is detecting subclinical coronary artery disease at the time of the CT scan. Secondary outcomes include linking artery calcium score, plaque characteristics, liver health, and artery stiffness to major cardiovascular events over 30 months. The study runs from September 2025 through September 2029 and is sponsored by Nantes University Hospital.
CONDITIONS
Brief Title
Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign the study consent form
- Affiliated with a current social security scheme
- Definite diagnosis of Familial Hypercholesterolemia by clinical-biological score > 8 or identified causal mutation
- Male aged 40 years or older, or female aged 50 years or older
- Able to understand French to complete questionnaires
- Not taking lipid-lowering medication or on stable dose for at least one month prior to inclusion (three months for PCSK9 inhibitors)
- Not taking antihypertensive medication or on stable dose for at least one month
- Not taking antidiabetic medication or on stable dose for at least 3 months
You will not qualify if you...
- Technical contraindication for coronary CT scan: patient diameter > 70 cm and/or weight > 250 kg
- History of atherosclerotic cardiovascular event (heart attack, ischemic heart disease, coronary revascularization, stroke, carotid endarterectomy, or lower limb arterial revascularization)
- Allergy to iodinated contrast agents
- Severe renal insufficiency (eGFR ≤ 30 ml/min)
- Active cancer or cancer remission less than 3 years
- Oral or intravenous corticosteroid therapy within last 6 months
- Untreated or poorly controlled hypothyroidism
- Receiving immunosuppressive or anticancer therapy
- Refusing to participate
- Under guardianship, curatorship, judicial protection, or without social insurance coverage
- Pregnant woman
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility verification, consent signing, clinical information collection, fasting blood draw, and optional sample collection and questionnaires.
Duration - Up to 6 months after the inclusion visit
Participants undergo a coronary CT scan with coronary artery calcium (CAC) score measurement to assess subclinical coronary atherosclerosis.
1 visit (in-person) for coronary CT scan and CAC score measurement
Duration - 30 months
Participants are monitored over 30 months to collect clinical information, questionnaires, biological samples, and major cardiovascular events via visits and telephone calls.
2 in-person visits (inclusion and 30 months) and telephone calls at 1 and 2 years
Trial Site Locations
Total: 9 locations
1
CHU Dijon Bourgogne
Dijon, France
Actively Recruiting
2
CHRU Lille
Lille, France
Not Yet Recruiting
3
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
4
Hôpital de la Conception, AP-HM
Marseille, France
Not Yet Recruiting
5
CHU Nantes
Nantes, France
Actively Recruiting
6
Hôpital de la Pitié-Salpêtrière, AP-HP
Paris, France
Actively Recruiting
7
Hôpital Saint-Antoine, AP-HP
Paris, France
Actively Recruiting
8
CHU Rennes
Rennes, France
Actively Recruiting
9
CHU Strasbourg
Strasbourg, France
Actively Recruiting
Research Team
B
Bertrand CARIOU, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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