Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 9
- 主要终点
- Presence of subclinical coronary atherosclerosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Single arm
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.
干预措施: Coronary CT scan with CAC score measurement (Other)
结局指标
主要结局
Presence of subclinical coronary atherosclerosis
时间窗: 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
次要结局
- Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).(30 months)
- Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile(30 months)
- Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months.(30 months)
- 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)
- Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months(30 months)
- Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months.(30 months)
- Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months(30 months)
- Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months(30 months)