MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Percentage of patients presenting with at least one micro infarction at RMI
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of patients presenting with at least one micro infarction at RMI
Time Frame: Within 4 weeks after consent signature
Cardiac and aortic RMI with gadolinium
Secondary Outcomes
- Anatomic and functional indexes of the aorta (maximal and minimal areas of aortic lumen, aortic flow)(Within 4 weeks after consent signature)
- LDL-Cholesterol burden (compared to standard values)(The most recent value within the last 5 years.)
- 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)