Viewing Study NCT03140605


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Study NCT ID: NCT03140605
Status: UNKNOWN
Last Update Posted: 2020-09-16
First Post: 2017-05-02
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Greek Registry - Familial Hypercholesterolaemia
Sponsor: Hellenic College of Treatment of Atherosclerosis
Organization:

Study Overview

Official Title: Hellenic Registry for Familial Hypercholesterolemia
Status: UNKNOWN
Status Verified Date: 2020-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GRegistry-FH
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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: