Greek Registry - Familial Hypercholesterolaemia

NCT ID: NCT03140605

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-10

Study Completion Date

2020-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In contrast, timely recognition and effective treatment of FH can result in a significant improvement in clinical outcomes. The problem is that that majority of individuals with FH are unaware of their disease, particularly that the disease remains silent for many years. In most countries around the world \<5% of individuals with FH are identified .

Until lately the prevalence of heFH was traditionally considered to be \~ 1:500 individuals , although clinical and genetic studies suggest that heFH affects \~ 1:200-250 individuals . Thus, the aim of the Hellenic College of Treatment of Atherosclerosis (HCAT) is to 1). Evaluate the prevalence of FH in Greece (FHG-Registry) and 2). To inform population of FH disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Familial Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* \<18 years, \>80 years
* deny to sign informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hellenic College of Treatment of Atherosclerosis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A

Cardiologist, Head of Hellenic College of Treatment of Atherosclerosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Onassis Cardiology Hospital

Athens, , Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Genovefa Kolovou, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Genovefa Kolovou, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17239976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17235114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20826022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26447655 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27678429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27794106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27939304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39728301 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-HPLS-IIS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epidemiology of Atherosclerosis
NCT00005147 COMPLETED