Atherosclerosis Clinical Trial
— CARDIOMETOfficial title:
Advanced Lipoproptein Profiling and Cardiovascular Risk Stratification in Familial Hypercholesterolemia
Familial hypercholesterolaemia (FH) is a genetic disorder characterised by elevated plasma LDLC levels. The causal role of low-density lipoprotein cholesterol (LDLC) in the progression of cardiovascular disease (CVD) is indisputable: genetic, epidemiological and interventional trials have unanimously shown that a reduction in LDL-C is associated with a reduced risk of CVD. Some drawbacks related to the limitations of the analytical methods are slowly surfacing due to the lower LDLC target achieved with the combination of several new treatments. This is mainly due to the fact that LDLC is not a comprehensive marker to stratify cardiovascular risk in subjects with increased levels of other atherogenic lipoproteins. Direct measurement of the concentration of apolipoproteins involved in cholesterol and triglycerides transportation, may provide more information than the simple measure of the cholesterol contained in these particles. There is an interest in measuring the various players involved in the lipoprotein processing chain. These apolipoproteins are increasingly being considered as possible biomarkers of cardiovascular disease risk. Indeed, there is increasing evidence that advanced lipoprotein testing methods, such as multiplexed measurements of apolipoprotein panels (ApoA-I, A-II, A-IV, B-100, C-I, C-II, C-III, E), provide more detailed information on the dyslipidaemic profiles of patients compared to conventional lipid testing, finally allowing a better understanding and stratification of subclinical atherosclerosis in these patients. The main objective of this study is to compare the apolipoprotein profile of patients with FH by comparing those with associated hypertriglyceridemia (hyperTG) to those with isolated hypercholesterolaemia. Adult subjects with a molecular diagnosis of Familial Hypercholesterolemia, treated by a statin, on primary prevention, asymptomatic for cardiovascular symptoms, will be recruited and stratified according to the presence/absence of hyperTG in a case-control prospective observational study design.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: A. Patients with familial hypercholesterolemia (FH) and with hyperTG : 1. Age > 18 years 2. Molecular or clinical diagnosis of FH 3. Primary prevention (no coronary artery disease, cerebrovascular disease or lower limb arterial disease) 4. HyperTG or TG levels between 135-500 mg/dl on statin therapy 5. Patient informed of the research, not having objected to participation and having provided written consent for genetic analysis B. Patients with familial hypercholesterolemia (FH) and without hyperTG : 1. Age > 18 years 2. Mild diagnosis 3. Primary prevention (no coronary artery disease, cerebrovascular disease or lower limb arterial disease) 4. TG <135mg/dl on statin therapy 5. Patient informed of the research, did not object to participation and provided written consent for genetic testing Exclusion Criteria: 1. Secondary prevention or planned coronary intervention or cardiac surgery 2. History of acute or chronic pancreatitis 3. Statin-intolerant patient 4. Glycated haemoglobin level greater than 10.0%. 5. Human Immunodeficiency Virus infection on treatment, 6. Use of corticosteroids 7. Severe renal impairment (Glomerular filtration rate < 30 ml/min) 8. Pregnant women |
Country | Name | City | State |
---|---|---|---|
France | Hôpital de la Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apolipoprotein score | Apolipoprotein score (ApoA-I, A-II, A-IV, B-100, C-I, C-II, C-III, E) will be measured in gram per liter (g/l) and assessed by liquid chromatography-mass spectrometry (LC-MS). | At day 1 | |
Secondary | Calcium score | The Calcium score will be measured in Hounsfield units (HU) and assessed using the Agatston method (such examination will be performed as part of the usual management of care). | At day 1 | |
Secondary | Intima-media thickening of the distal common carotid artery | Measurement of intima-media thickening of the distal common carotid artery, quantified by Doppler ultrasound using semi-automated calculation software. | At day 1 | |
Secondary | Presence of carotid plaque | Presence of carotid plaque assessed by the European Carotid Surgery Trial (ECST) method | At day 1 | |
Secondary | Intima-media thickening of the distal common femoral artery | Measurement of intima-media thickening of the distal common femoral artery, quantified by Doppler ultrasound using semi-automated calculation software. | At day 1 | |
Secondary | Presence of femoral plaque | Presence of femoral plaque assessed by the European Carotid Surgery Trial (ECST) method | At day 1 |
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