NCT03110250

Brief Summary

A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution.\[14\] Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 26, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

9 months

First QC Date

April 3, 2017

Last Update Submit

December 5, 2017

Conditions

Keywords

Familial HypercholesterolemiaregistryTurkeyLipid lowering therapy

Outcome Measures

Primary Outcomes (1)

  • number of patients receiving proper treatment for FH

    how many patients are receieving the proper lipid lowering drugs for the diagnosis of FH

    February- November 2017

Secondary Outcomes (1)

  • number of patients reaching LDL-cholesterol goal according to risk status (risk level)

    February- November 2017

Eligibility Criteria

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

At least 1000 Familial Hypercholesterolemia (FH) patients are being recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution. Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.

You may qualify if:

  • age \> 18 years and being diagnosed as possible FH.
  • The possible FH was defined as having a total score of \> 2 according to Dutch lipid clinic network (DLCN) criteria

You may not qualify if:

  • Patients with triglyceride levels \> 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Medical School

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type IIAtherosclerosis

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Meral Kayikcioglu

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor MD

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 12, 2017

Study Start

February 26, 2017

Primary Completion

November 30, 2017

Study Completion

December 5, 2017

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations