NCT05825612Not yet recruiting
EPIRUS FH Reverse Cascade Screening
Reverse Cascade Screening for Familial Hypercholesterolemia in Children and Adolescents in Northwest Greece
Source: ClinicalTrials.gov · Last updated 24 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Familial hypercholesterolemia (FH) is the most common inherited metabolic disorder resulting in marked elevations in low-density lipoprotein cholesterol (LDL-C). If left untreated, lifelong exposure to elevated LDL-C leads to a substantially increased risk of premature cardiovascular disease as compared to the general population. Although FH adverse cardiovascular outcomes are potentially preventable through early identification of FH individuals and initiation of effective treatment, available evidence shows that FH is under-diagnosed and under-treated. Childhood is the optimal period for FH screening, because due to minimal dietary and hormonal influences, LDL-C levels reflect predominantly the genetic component in children and are well suited to discriminate FH from other causes of elevated LDL-C. If FH remains untreated in this latent stage of the disease, individuals show a 10-fold increase of cardiovascular risk during early and middle adulthood. In this context, an effective approach for detecting FH would be a screening during childhood or in young adolescents in combination with reverse cascade screening of first-degree relatives of FH individuals. EPIRUS-FH registry is a model program of reverse cascade screening for FH in children and adolescents in Northwest Greece that aims to increase public and physician awareness, strengthen the national registry of familial hypercholesterolemia (HELLAS-FH) and constitute the core for a national FH registry in children and adolescents in Greece.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 11 Apr 2023
- Start date
- May 2023
- Primary completion date
- May 2033
- Lead sponsor
- Hellenic Atherosclerosis Society
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05825612
What you commit to
- Study type: Observational
- Planned participants: 1000
- From May 2023 to the primary completion date, May 2033
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any clinically significant disorder recognized at the time of the preliminary assessment, which in the judgment of the investigator would disqualify patient's participation in the study.
Other
- Refusal to sign the consent form and disagreement with the terms of participation.
Who the study is looking for
- LDL-C \>160 mg/dL on two seperate measurements 3 months apart
- LDL-C \>130 mg/dL + family history of premature coronary artery disease or hypercholesterolemia in one parent
- Children and adolescents on cholesterol-lowering medication
Age in the registry: 4 years to 16 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.