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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02013713
Other study ID # 12 449
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2014
Est. completion date December 2016

Study information

Verified date August 2019
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France European Hospital Georges Pompidou Paris

Sponsors (1)

Lead Sponsor Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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