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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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Patients with familial hypercholesterolemia (FH) at high cardiovascular risk may suffer from silent micro-infarctions (MI) before clinical coronary heart disease manifestations because of the lifetime exposure to elevated serum LDL-cholesterol levels.
The study aims to demonstrate the higher prevalence of silent myocardial infarction in a population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular risk in comparison to control patients using Cardiac Magnetic Resonance sequences of delayed gadolinium enhancement.
To demonstrate the higher prevalence of silent myocardial infarction in a population of asymptomatic patients with familial hypercholesterolemia at high cardiovascular risk in comparison to control patients, the protocol is the following:
The study will be performed according to GCPs and with respect with french laws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Familial hypercholesterolemia patients |
| ||
| Control group |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients presenting with at least one micro infarction at RMI | Cardiac and aortic RMI with gadolinium | Within 4 weeks after consent signature |
| Measure | Description | Time Frame |
|---|---|---|
| LDL-Cholesterol burden (compared to standard values) | The most recent value within the last 5 years. | |
| Anatomic and functional indexes of the aorta (maximal and minimal areas of aortic lumen, aortic flow) | Within 4 weeks after consent signature |
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Inclusion criteria:
For patients with heterozygous form of familial hypercholesterolemia:
Aged between 40 and 60 years
With an identified genetic mutation (LDL-R, ApoB, PCSK9)
Asymptomatic,
With no EKG sign of ischemia
No personal history of coronary heart disease.
Treated or untreated by lipid lowering treatment
High cardiovascular risk identified by 1 of the following criteria:
1. Current smoking (1 cigarette a day) 2 Family history of very premature onset CHD: first- or second-degree male relative onset before age 45, first- or second-degree female relative onset before age 55 3.Two or more cardiovascular risk factors among this list: increasing age (men > 30, women > 40 years of age), LDL-C > 250 mg/dL, male sex, family history of premature onset CHD, first-degree male relative onset before age 55, first-degree female relative onset before age 65, metabolic syndrome, HDL-C < 40 mg/dL, hypertension (BP > 140/or > 90 mmHg or drug treatment), Lp (a) ≥ 50 mg/dL, tendon xanthoma
For control subjects:
Exclusion criteria:
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110 subjects divided into:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurélie RABIER | Contact | a.rabier@ican-institute.org |
| Name | Affiliation | Role |
|---|---|---|
| David Rosenbaum, MD | Study principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de prévention des maladies cardiovasculaires- Unité INSERM 939 Pôle Cardiologie/Métabolisme Groupe Hospitalier Pitié-Salpêtrière | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23416791 | Background | Hovingh GK, Davidson MH, Kastelein JJ, O'Connor AM. Diagnosis and treatment of familial hypercholesterolaemia. Eur Heart J. 2013 Apr;34(13):962-71. doi: 10.1093/eurheartj/eht015. Epub 2013 Feb 14. | |
| 21191428 | Background | Nemati MH, Astaneh B. Optimal management of familial hypercholesterolemia: treatment and management strategies. Vasc Health Risk Manag. 2010 Dec 3;6:1079-88. doi: 10.2147/VHRM.S8283. |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Correlations between LDL-Cholesterol burden & presence of micro infarction, between LDL-Cholesterol burden & myocardial fibrosis, and between LDL-Cholesterol burden & aortic stiffness indexes | 1 year |
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| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |