Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362473
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-02
Brief Title:
Lipid Transport Disorder Italian Genetic Record LIPIGEN
Sponsor:
Fondazione SISA Societa Italiana per lo Studio della Arteriosclerosi
Organization:
Fondazione SISA Societa Italiana per lo Studio della Arteriosclerosi
Study Overview
Official Title:
Lipid Transport Disorder Italian Genetic Record LIPIGEN
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
LIPIGEN
Brief Summary:
LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias including very common conditions such as familial hypercholesterolaemia FH and less common ones such as familial chylomicronidaemic syndrome FCS
What does the study do
It collects information on Italian patients with Familial Hypercholesterolaemia FH following them in their normal clinical examination without adding extra procedures
It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia examining how it is diagnosed clinically and by genetic testing and evaluating the effectiveness of different treatments
It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias helping to choose the most effective treatments
It evaluates the impact of long-term treatments and patient adherence to medication as well as monitoring the incidence of cardiovascular events and other important outcomes
Who can participate
The study is aimed at people of all ages from children to adults with familial hypercholesterolaemia or other genetic dyslipidaemia
More than 50 centres throughout Italy are involved making the study accessible to many
What does participation entail
Participants will continue with their normal clinical practice
Data such as family history personal clinical findings and genetic information will be collected without additional procedures
For some further evaluations such as ultrasounds may be required to better study their condition
The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients39 lives through more precise diagnosis and personalised treatments
What does the study do
It collects information on Italian patients with Familial Hypercholesterolaemia FH following them in their normal clinical examination without adding extra procedures
It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia examining how it is diagnosed clinically and by genetic testing and evaluating the effectiveness of different treatments
It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias helping to choose the most effective treatments
It evaluates the impact of long-term treatments and patient adherence to medication as well as monitoring the incidence of cardiovascular events and other important outcomes
Who can participate
The study is aimed at people of all ages from children to adults with familial hypercholesterolaemia or other genetic dyslipidaemia
More than 50 centres throughout Italy are involved making the study accessible to many
What does participation entail
Participants will continue with their normal clinical practice
Data such as family history personal clinical findings and genetic information will be collected without additional procedures
For some further evaluations such as ultrasounds may be required to better study their condition
The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients39 lives through more precise diagnosis and personalised treatments
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None