Status:
COMPLETED
Study of cardiovAscular Contrasted Phenotypes in Patients With FamIliaI hypercholesteRolemia
Lead Sponsor:
Nantes University Hospital
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The main objective of SAFIR is to identify the atherosclerotic genetic factors in these patients, which will identify new therapeutic targets for the treatment of CV and Familial Hypercholesterolemia ...
Detailed Description
The objective of the SAFIR study is to perform non-invasive coronary vascular phenotyping of familial hypercholesterolemia (FH) families by performing a coronary calcium score and then to detect prote...
Eligibility Criteria
Inclusion
- Patient agreeing to sign the consent of the study and the consent of biocollection
- Patient suffering from a familial hypercholesterolemia with a clinically-biologic score DLCN (Dutch Lipid Clinic Network, Annex 2)\> 8 and / or a causative mutation identified in the LDL receptor genes, apolipoprotein B100 or Of PCSK9.
- Men ≥ 40 years of age; Female ≥ 50 years
- Patient affiliated to an existing social insurance
- The inclusion criteria to be met in the population with known coronary atheroma:
- Subject in secondary prevention of an atheromatous disease: coronary event or ischemic heart disease, irrespective of the result of the coronary calcium score; Ischemic stroke with proven carotid atheromatosis; revascularization (angioplasty, bypass surgery) or amputation in PAD
- Primary prevention topic CV with calcium score ≥ 400 Agatston units
- Inclusion criteria to be met in the population without cardiovascular risk:
- \- No cardiovascular event (including MI, coronary revascularization, angina, stroke \&, Transiant ischemic attack of atheromatous origin, PAD) with: For women between 50 and 65 years, a nil calcium score \* For women between 65 and 75 years of age, a calcium score\*\* ≤ 10 Agatston units For women over 75 years of age, a calcium score\*\* ≤ 20 Agatston units For men between 40 and 55 years of age, a nil calcium score\* for men For men between 55 and 70 years of age, a calcium score\*\* ≤ 10 Agatston units For men over 70 years of age, a calcium score\*\* ≤ 20 Agatston units
- 40 year old men and 50 year old women: less than 6 months old
- 41 year old men and 51 year old women: under 1 year old
- 42 year old men and 52 year old women: under 2 years old
- 43 year old men and 53 year old women: under 3 years old
- 44 year old men and 54 year old women: under 4 years old
- Less than 5 years
- Inclusion criteria to be met in the related population with familial hypercholesterolemia :
- Patient agreeing to sign the consent of the study and the consent of biocollection
- Patient suffering from a familial hypercholesterolemia with a clinically-biologic score DLCN (Dutch Lipid Clinic Network, Annex 2)\> 8 and / or a causative mutation identified in the LDL receptor genes, apolipoprotein B100 or Of PCSK9.
- Men or Female ≥ 30 years
- Patient affiliated to an existing social insurance
- Inclusion criteria to be met in the related population without familial hypercholesterolemia :
- Patient agreeing to sign the consent of the study and the consent of biocollection
- Patient not suffering from a familial hypercholesterolemia related to one of the members of the population suffering from familial hypercholesterolemia without cardiovascular risk
- Men or Female ≥ 18 years
- Patient affiliated to an existing social insurance
Exclusion
- Subject suffering from active cancer or progressive neoplasia
- Subject treated with recent corticosteroid therapy
- Subjects with unsubstituted or poorly controlled hypothyroidism (TSH\> normal)
- Subject receiving immunosuppressive or anti-cancer treatment
- Subject refusing to participate
- Subjects under tutelage, curatorship or a safeguard of justice or without social insurance
- The exclusion criterion for all populations except the related population without familial hypercholesterolemia:
- \- Subject with no "definite" familial hypercholesterolemia according to the DLCN score (≤8), after auction. The purpose of the auction will be to rule on the causal nature of an identified mutation.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2021
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT03234127
Start Date
December 6 2017
End Date
May 6 2021
Last Update
May 24 2021
Active Locations (9)
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1
Le Bocage Hospital
Dijon, France, 29079
2
CHRU de Lille
Lille, France, 59037
3
Louis Pradel Cardiovascular Hospital
Lyon, France, 69677
4
La Conception Hospital
Marseille, France, 13285