NCT02013713

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

December 6, 2013

Last Update Submit

August 6, 2019

Conditions

Keywords

CardiologyFamily Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Family Hypercholesterolemia in cardiology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Expressed refusal to participate in the observatory
  • Age ≤ 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital Georges Pompidou

Paris, 75015, France

Location

Related 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. doi: 10.1016/j.atherosclerosis.2003.11.010.

    PMID: 15177124BACKGROUND

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 17, 2013

Study Start

November 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations