Clinical Trial: MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA
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 Summary:
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.
Sponsor: Institute of Cardiometabolism and Nutrition, France
Current Primary Outcome: Percentage of patients presenting with at least one micro infarction at RMI [ Time Frame: Within 4 weeks after consent signature ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- LDL-Cholesterol burden (compared to standard values) [ Time Frame: 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) [ Time Frame: Within 4 weeks after consent signature ]
- Correlations between LDL-Cholesterol burden & presence of micro infarction, between LDL-Cholesterol burden & myocardial fibrosis, and between LDL-Cholesterol burden & aortic stiffness indexes [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Institute of Cardiometabolism and Nutrition, France
Dates:
Date Received: January 14, 2015
Date Started: November 2014
Date Completion: November 2015
Last Updated: August 4, 2015
Last Verified: July 2015