NCT03140605

Brief Summary

Familial hypercholesterolemia (FH) \[heterozygous (heFH) or homozygous FH (hoFH)\] is a common genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and extensor tendons, rapidly progressing vascular disease, and aortic valve disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3.9 years

First QC Date

May 2, 2017

Last Update Submit

September 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • the prevalence of Familiar Hypercholesterolaemia in Greece

    patients with FH will be screened and include in Registry

    1 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sample of citizents on Panhellenic basis

You may qualify if:

  • both genders
  • \>18 years, \<80 years
  • door to door enrolment
  • eligible to sign informed consent

You may not qualify if:

  • \<18 years, \>80 years
  • deny to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onassis Cardiology Hospital

Athens, Greece

RECRUITING

Related Publications (8)

  • Kolovou GD, Damaskos DS, Anagnostopoulou KK, Salpea KD, Dritsas A, Giannakopoulou V, Vasiliadis IK, Cokkinos DV. Stress testing response in women heterozygous for familial hypercholesterolemia. Int J Cardiol. 2007 Oct 31;122(1):96-7. doi: 10.1016/j.ijcard.2006.11.046. Epub 2007 Jan 18.

    PMID: 17239976BACKGROUND
  • Kolovou GD, Dedoussis GV, Anagnostopoulou KK, Hatzigeorgiou GCh, Salpea KD, Choumerianou DM, Rammos S, Mikhailidis DP, Cokkinos DV. Management of a patient with a null low-density lipoprotein receptor mutation: a case report. Angiology. 2006 Dec-2007 Jan;57(6):729-32. doi: 10.1177/0003319706294421.

    PMID: 17235114BACKGROUND
  • Kolovou GD, Kostakou PM, Anagnostopoulou KK. Familial hypercholesterolemia and triglyceride metabolism. Int J Cardiol. 2011 Mar 17;147(3):349-58. doi: 10.1016/j.ijcard.2010.08.009. Epub 2010 Sep 9.

    PMID: 20826022BACKGROUND
  • Markousis-Mavrogenis G, Mavrogeni S, Kolovou G. Early coronary artery disease--Usual and unusual suspects. Int J Cardiol. 2016 Jan 1;202:511. doi: 10.1016/j.ijcard.2015.09.050. Epub 2015 Sep 25. No abstract available.

    PMID: 26447655BACKGROUND
  • Beliard S, Millier A, Carreau V, Carrie A, Moulin P, Fredenrich A, Farnier M, Luc G, Rosenbaum D, Toumi M, Bruckert E; French FH Registry group. The very high cardiovascular risk in heterozygous familial hypercholesterolemia: Analysis of 734 French patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1129-1136.e3. doi: 10.1016/j.jacl.2016.06.007. Epub 2016 Jun 27.

    PMID: 27678429BACKGROUND
  • Mundal L, Igland J, Ose L, Holven KB, Veierod MB, Leren TP, Retterstol K. Cardiovascular disease mortality in patients with genetically verified familial hypercholesterolemia in Norway during 1992-2013. Eur J Prev Cardiol. 2017 Jan;24(2):137-144. doi: 10.1177/2047487316676135. Epub 2016 Oct 28.

    PMID: 27794106BACKGROUND
  • EAS Familial Hypercholesterolaemia Studies Collaboration; Vallejo-Vaz AJ, Akram A, Kondapally Seshasai SR, Cole D, Watts GF, Hovingh GK, Kastelein JJ, Mata P, Raal FJ, Santos RD, Soran H, Freiberger T, Abifadel M, Aguilar-Salinas CA, Alnouri F, Alonso R, Al-Rasadi K, Banach M, Bogsrud MP, Bourbon M, Bruckert E, Car J, Ceska R, Corral P, Descamps O, Dieplinger H, Do CT, Durst R, Ezhov MV, Fras Z, Gaita D, Gaspar IM, Genest J, Harada-Shiba M, Jiang L, Kayikcioglu M, Lam CS, Latkovskis G, Laufs U, Liberopoulos E, Lin J, Lin N, Maher V, Majano N, Marais AD, Marz W, Mirrakhimov E, Miserez AR, Mitchenko O, Nawawi H, Nilsson L, Nordestgaard BG, Paragh G, Petrulioniene Z, Pojskic B, Reiner Z, Sahebkar A, Santos LE, Schunkert H, Shehab A, Slimane MN, Stoll M, Su TC, Susekov A, Tilney M, Tomlinson B, Tselepis AD, Vohnout B, Widen E, Yamashita S, Catapano AL, Ray KK. Pooling and expanding registries of familial hypercholesterolaemia to assess gaps in care and improve disease management and outcomes: Rationale and design of the global EAS Familial Hypercholesterolaemia Studies Collaboration. Atheroscler Suppl. 2016 Dec;22:1-32. doi: 10.1016/j.atherosclerosissup.2016.10.001. Epub 2016 Dec 7.

    PMID: 27939304BACKGROUND
  • Kolovou G, Makrygiannis S, Marvaki C, Pavlatou N, Anagnostopoulou K, Giannakopoulou V, Goumas G, Kalogeropoulos P, Kolovou V, Limberi S, Perrea D, Tzenalis A, Emre Z, Jahaj E, Kasiara Z, Giannakoulis I, Tsolakoglou I, Kadda O, Tsaloukidis N, Koulaxidou R, Marvaki A, Foussas S, Melidonis A, Hoursalas G, Vlachopoulos C, Katsiki N, Milionis H, Liberopoulos E, Bilianou H. Prevalence and Risk Factors for Atherosclerotic Cardiovascular Disease in 7704 Individuals: An Analysis from the Greek Registry for the Prevalence of Familial Hypercholesterolemia (GRegistry-FH). J Cardiovasc Dev Dis. 2024 Dec 23;11(12):411. doi: 10.3390/jcdd11120411.

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

Central Study Contacts

Genovefa Kolovou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist, Head of Hellenic College of Treatment of Atherosclerosis

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

January 10, 2017

Primary Completion

December 10, 2020

Study Completion

December 10, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations