Study of the Determinants of Coronary Atherosclerosis in Familial Hypercholesterolemia (ATHERO-FH Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorNantes University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Coronary CT scan with CAC score measurement
Other interventionCoronary CT scan with CAC score measurement (on the same day or within 6 months after the inclusion visit).
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Single armOther 1 intervention
Trial outcomes
Primary outcomes
1
Presence of subclinical coronary atherosclerosis
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
Time frame
At the time of performing the coronary CT scanSecondary outcomes
1
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The anthropometric data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Time frame
30 months2
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The clinic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study
Time frame
30 months3
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The drug treatments collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Time frame
30 months4
Identification of factors associated with the presence or absence of subclinical coronary atherosclerosis (coronary stenosis > 50% on coronary CT scan).
The genetic data collected as part of the current study will be comparable to the data collected as part of the SAFIR study.
Time frame
30 monthsSponsors and contacts
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Source ClinicalTrials.gov