MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR)

Institute of Cardiometabolism and Nutrition, France

Status

Unknown

Conditions

Familial Hypercholesterolemia - Heterozygous

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02517944

14DRM_CHOLCOEUR

Details and patient eligibility

About

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.

Full description

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:

to enroll 75 patients with familial hypercholesterolemia (FH)
to enroll 35 subjects without FH (control group)
for each subject, to collect data from his medical file (blood test results) and to perform a cardiac and aortic MRI in order to evaluate the micro-infarction proportion.

The study will be performed according to GCPs and with respect with french laws.

Enrollment

110 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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:

Aged between 40 and 60 years
With a normal lipid profile (LDL-C < 1.6g/L HDL-C > 0,45g/L and TG < 4g/L) and untreated by any lipid lowering therapies
Asymptomatic,
With EKG showing normal sinus rhythm , no sign of ischemia nor Left Bundle Branch Block
No personal history of coronary heart disease.
Control subjects will be matched for age/gender/smoking status and blood pressure

Exclusion criteria

Non-affiliation to a healthcare system
Consent refusal
Contra-indication to MRI or to gadolinium injection.
Claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, pregnancy, nursing
Renal failure
Technical contra-indication: patient diameter > 70 cm weight > 250 kg
Personal history of cardiovascular disease and myocardial infarction
Diabetes mellitus
Uncontrolled hypertension
TG < 4 g/L
Previous use of an Amgen product in the past 12 months