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Trial record 2 of 153 for:    "familial hypercholesterolemia"

MYOCARDIAL SILENT INFARCTIONS AND FIBROSIS IN FAMILIAL HYPERCHOLESTEROLEMIA (CHOLCOEUR) (CHOLCOEUR)

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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
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Institute of Cardiometabolism and Nutrition, France

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.


Condition or disease
Familial Hypercholesterolemia - Heterozygous

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 Type : Observational [Patient Registry]
Estimated Enrollment : 110 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Familial hypercholesterolemia patients
  • clinical data
  • biological data
  • cardiac and aortic RMI with gadolinium
Control group
  • clinical data
  • biological data
  • cardiac and aortic RMI with gadolinium



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. LDL-Cholesterol burden (compared to standard values) [ Time Frame: The most recent value within the last 5 years. ]
  2. Anatomic and functional indexes of the aorta (maximal and minimal areas of aortic lumen, aortic flow) [ Time Frame: Within 4 weeks after consent signature ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

110 subjects divided into:

  • 75 patients with heterozygous form at high cardiovascular risk
  • 35 controls patients without dyslipidaemia
Criteria

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

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

Information from the National Library of Medicine

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


Contacts
Contact: Aurélie RABIER a.rabier@ican-institute.org

Locations
France
Unité de prévention des maladies cardiovasculaires- Unité INSERM 939 Pôle Cardiologie/Métabolisme Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: David Rosenbaum, MD       david.rosenbaum@psl.aphp.fr   
Contact: Eric Bruckert, Pr       eric.bruckert@psl.aphp.fr   
Sponsors and Collaborators
Institute of Cardiometabolism and Nutrition, France
Amgen
Investigators
Principal Investigator: David Rosenbaum, MD Study principal investigator

Publications:

Responsible Party: Institute of Cardiometabolism and Nutrition, France
ClinicalTrials.gov Identifier: NCT02517944     History of Changes
Other Study ID Numbers: 14DRM_CHOLCOEUR
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: July 2015

Keywords provided by Institute of Cardiometabolism and Nutrition, France:
Familial hypercholesterolemia

Additional relevant MeSH terms:
Infarction
Hypercholesterolemia
Hyperlipoproteinemia Type II
Ischemia
Pathologic Processes
Necrosis
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias