French Observatory of Familial Hypercholesterolemia in Ca... | NCT02013713

Studies
French Observatory of Familial Hypercholesterolemia in Cardiology

NCT02013713

Sponsor

French Cardiology Society

Status

Terminated

Last Update Posted

Aug 7, 2019Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Familial Hypercholesterolemia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of enrollment

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Dec 6, 2013

First Submission Date that Met QC Criteria

Dec 11, 2013

First Posted Date

Dec 17, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
Family Hypercholesterolemia in cardiology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of the Family Hypercholesterolemia in cardiology	Number of Family Hypercholesterolemia among patients with LDL-C> 1.9g / l without hypoglycemic treatment or> 1.6g / l in lipid-lowering therapy	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

* 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
European Hospital Georges Pompidou		Paris		75015	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15177124	Background	Civeira F; International Panel on Management of Familial Hypercholesterolemia. Guidelines for the diagnosis and management of heterozygous familial hypercholesterolemia. Atherosclerosis. 2004 Mar;173(1):55-68. doi: 10.1016/j.atherosclerosis.2003.11.010.

ID	Term
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities