Study to Understand Coronary Atherosclerosis in Familial Hypercholesterolemia Using Coronary CT Scans and Calcium Scores in Adults with Heart Disease Risk

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.

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