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Greek Registry - Familial Hypercholesterolaemia (GRegistry-FH)

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ClinicalTrials.gov Identifier: NCT03140605
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A, Hellenic College of Treatment of Atherosclerosis

Tracking Information
First Submitted Date May 2, 2017
First Posted Date May 4, 2017
Last Update Posted Date February 27, 2019
Actual Study Start Date January 10, 2017
Estimated Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2017)
the prevalence of Familiar Hypercholesterolaemia in Greece [ Time Frame: 1 month ]
patients with FH will be screened and include in Registry
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03140605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Greek Registry - Familial Hypercholesterolaemia
Official Title Hellenic Registry for Familial Hypercholesterolemia
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Month
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Sample of citizents on Panhellenic basis
Condition Familial Hypercholesterolemia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 10, 2019
Estimated Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Genovefa Kolovou, MD genovefa@kolovou.com
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT03140605
Other Study ID Numbers 2017-HPLS-IIS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A, Hellenic College of Treatment of Atherosclerosis
Study Sponsor Hellenic College of Treatment of Atherosclerosis
Collaborators Not Provided
Investigators Not Provided
PRS Account Hellenic College of Treatment of Atherosclerosis
Verification Date February 2019