Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03520140
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2018-04-13
Brief Title:
Prevalence of Familial Hypercholesterolaemia FH in Italian Patients With Coronary Artery Disease
Sponsor:
Heart Care Foundation
Organization:
Heart Care Foundation
Study Overview
Official Title:
Prevalence of Familial Hypercholesterolaemia FH in Italian Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2018-04
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:
POSTER
Brief Summary:
Evaluate the prevalence of familial hypercholesterolemia FH in patients with documented coronary artery disease CAD event acute myocardial infarction AMI acute coronary syndrome ACS coronary artery bypass graft CABG or percutaneous coronary intervention PCI followed by 100 cardiological centers representative of the whole Italian territory
Detailed Description:
Familial hypercholesterolemia FH is a disease that causes exposure to elevated plasma levels of LDL cholesterol LDL-C low-density lipoprotein and increasing the risk of premature coronary heart disease coronary artery disease CAD The FH is a co-dominant genetic disease and can occur in heterozygous and homozygous form with different severity The prevalence in whites is estimated to be 1500 for heterozygous familial hypercholesterolemia HeFH and 11000000 for homozygous familial hypercholesterolemia HoFH This prevalence is probably an underestimate as it is based on prevalence rates in in-patient and disease registries and is influenced by the early mortality of patients with FH The situation does not improve if we consider patients admitted for acute coronary event myocardial infarction - AMI and or unstable angina - ACS If we consider LDL cholesterol cumulative load in a person affected by FH the best approach intervention to reduce cardiovascular mortality is an early diagnosis and treatment
The primary aim of the study is to evaluate the prevalence of FH in patients with documented CAD event AMI ACS CABG or PCI followed by 100 cardiologic centers representative of the whole Italian territory The results will also permit to increase the cardiologists awareness of FH Secondary objective will be the validation of Dutch Lipid Clinic Network DLCN criteria annex 1 in the Italian CAD population 12 The characterization of the patients carried out during the study will allow to identify the priorities for health inteventions aimed at improving the FH diagnosis in the general population through the a cascade screening in the relatives of the genetically characterized subjects
The primary aim of the study is to evaluate the prevalence of FH in patients with documented CAD event AMI ACS CABG or PCI followed by 100 cardiologic centers representative of the whole Italian territory The results will also permit to increase the cardiologists awareness of FH Secondary objective will be the validation of Dutch Lipid Clinic Network DLCN criteria annex 1 in the Italian CAD population 12 The characterization of the patients carried out during the study will allow to identify the priorities for health inteventions aimed at improving the FH diagnosis in the general population through the a cascade screening in the relatives of the genetically characterized subjects
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