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 ]

Cardiac and aortic RMI with gadolinium


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