MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR) (CHOLCOEUR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02517944|
Recruitment Status : Unknown
Verified July 2015 by Institute of Cardiometabolism and Nutrition, France.
Recruitment status was: Recruiting
First Posted : August 7, 2015
Last Update Posted : August 7, 2015
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.
|Condition or disease|
|Familial Hypercholesterolemia - Heterozygous|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||110 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||November 2015|
Familial hypercholesterolemia patients
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517944
|Contact: Aurélie RABIERemail@example.com|
|Unité de prévention des maladies cardiovasculaires- Unité INSERM 939 Pôle Cardiologie/Métabolisme Groupe Hospitalier Pitié-Salpêtrière||Recruiting|
|Paris, France, 75013|
|Contact: David Rosenbaum, MD firstname.lastname@example.org|
|Contact: Eric Bruckert, Pr email@example.com|
|Principal Investigator:||David Rosenbaum, MD||Study principal investigator|