Atherosclerotic Cardiovascular Disease (ASCVD), Familial Hypercholesterolemias
Conditions
Keywords
Familial hypercholesterolemia, atherosclerotic cardiovascular disease
Brief summary
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.
Interventions
OTHERCoronary CT scan with CAC score measurement
Coronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).
Sponsors
Nantes University Hospital
France 2030 program
European Union Next Generation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pathophysiology study
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of subclinical coronary atherosclerosis | 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
| Measure | Time frame | Description |
|---|---|---|
| Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan). | 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 |
| Identification of factors associated with a coronary calcium score less than or equal to the 25th percentile | 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 |
| Study of the association between the characteristics of coronary atheroma plaque on coronary CT and major cardiovascular events at 30 months. | 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). |
| 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 | 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 |
| Study of the association between the percentile of the coronary calcium score and major cardiovascular events and overall mortality at 30 months | 30 months | Assess the occurrence of major cardiovascular events and mortality according to the percentile of the coronary calcium score. |
| Study of the association between arterial stiffness and major cardiovascular events and overall mortality at 30 months. | 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 |
| Study of the association between the presence of hepatic steatosis and major cardiovascular events and overall mortality at 30 months | 30 months | Evaluer la survenue des événements cardiovasculaires majeurs et la mortalité en fonction de la stéatose hépatique |
| Study of the association between the presence of liver fibrosis and major cardiovascular events and all-cause mortality at 30 months | 30 months | Assess the occurrence of major cardiovascular events and mortality according to the presence of liver fibrosis |
Countries
France
Contacts
CONTACTBertrand CARIOU, Pr
Outcome results
None listed