French Observatory of Familial Hypercholesterolemia in Cardiology (FH Care)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by French Cardiology Society
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT02013713
First received: December 6, 2013
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The Family Hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. However, the Family Hypercholesterolemia exposes patients concerned at increased cardiovascular risk.

The frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management.

Main objectives:

  • Establish a monitoring patients with hypercholesterolemia Family cardiology in France
  • Characterize the Family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.

Condition
Familial Hypercholesterolemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Observatory of Familial Hypercholesterolemia in Cardiology

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Frequency of the Family Hypercholesterolemia in cardiology [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Number of Family Hypercholesterolemia among patients with LDL-C> 1.9g / l without hypoglycemic treatment or> 1.6g / l in lipid-lowering therapy


Estimated Enrollment: 200
Study Start Date: October 2014
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
Family Hypercholesterolemia in cardiology

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study is proposed to cardiology services hospitals. Aged 18 or more, seen in cardiology (USIC, Hospitalization, Consultation), who agreed to participate in the observatory, and coronary patients who have LDL-c levels

Criteria

Inclusion Criteria:

  • coronary patients
  • who agreed to participate
  • high LDL-c levels: * LDL-c> = 1.9g / l without lipid lowering treatment according to the diagnostic score of Family Hypercholesterolemia these coronary patients with LDL> 1.9g / l may possibly or probably be achieved Hypercholesterolemia Family.

or

* LDL-c> = 1.6g / l in lipid-lowering treatment, the reduction of LDL-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved Family Hypercholesterolemia after the diagnostic score.

Exclusion Criteria:

  • Expressed refusal to participate in the observatory
  • Age ≤ 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013713

Contacts
Contact: Albert HAGEGE 33(1) 43 22 33 33 edrouet@sfcardio.fr
Contact: Geneviève MULAK 33(1) 44 90 70 35 edrouet@sfcardio.fr

Locations
France
European Hospital Georges Pompidou Not yet recruiting
Paris, France, 75015
Contact: Albert Hagège         
Contact: Geneviève Mulak    +33 (0)1 44 90 70 28    edrouet@cardio-sfc.org   
Principal Investigator: Albert Hagège         
Sponsors and Collaborators
French Cardiology Society
  More Information

Publications:
Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT02013713     History of Changes
Other Study ID Numbers: 12 449
Study First Received: December 6, 2013
Last Updated: July 8, 2014
Health Authority: France : CNIL (National Commission on Onformatics and Freedoms) - Authorization N°912411

Keywords provided by French Cardiology Society:
Cardiology
Family Hypercholesterolemia

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

ClinicalTrials.gov processed this record on October 01, 2014