MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR)
NCT ID: NCT02517944
Last Updated: 2015-08-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
110 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-11-30
Study Completion Date
2015-11-30
Brief Summary
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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.
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.
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Detailed Description
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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.
* 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.
Conditions
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Familial Hypercholesterolemia - Heterozygous
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Familial hypercholesterolemia patients
* clinical data
* biological data
* cardiac and aortic RMI with gadolinium
No interventions assigned to this group
Control group
* clinical data
* biological data
* cardiac and aortic RMI with gadolinium
No interventions assigned to this group
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Amgen
INDUSTRY
Sponsor Role
collaborator
Institute of Cardiometabolism and Nutrition, France
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Rosenbaum, MD
Role: PRINCIPAL_INVESTIGATOR
Study principal investigator
Locations
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Unité de prévention des maladies cardiovasculaires- Unité INSERM 939 Pôle Cardiologie/Métabolisme Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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14DRM_CHOLCOEUR
Identifier Type: -
Identifier Source: org_study_id
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