Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease (POSTER)
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| ClinicalTrials.gov Identifier: NCT03520140 |
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Recruitment Status :
Completed
First Posted : May 9, 2018
Last Update Posted : October 9, 2020
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| Condition or disease |
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| Coronary Artery Disease |
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 1.500 for heterozygous familial hypercholesterolemia (HeFH) and 1.1000000 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.
| Study Type : | Observational |
| Actual Enrollment : | 5415 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease |
| Actual Study Start Date : | June 15, 2016 |
| Actual Primary Completion Date : | May 30, 2018 |
| Actual Study Completion Date : | May 30, 2018 |
- Familial hypercholesterolemia diagnosis [ Time Frame: Inclusion ]
Dutch Lipid Clinic Network Score (DLCNS) for FH The DLCNS is a validated set of criteria based on the patients family history of premature cardiovascular disease (CVD) in their first degree relatives, their own CVD history, their untreated lipid levels and physical signs such as the presence of tendon xanthomata or arcus cornealis prior to the age of 45. The subsequent score categorizes patients by the likelihood of Familial Hypercholesterolaemia (FH) diagnosis.
Definite FH if score >8 Probable FH if score 6-8 Possible FH if score 3-5 Unlikely FH if score <3
- Genetic examination [ Time Frame: Inclusion ]Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients must have a documented coronary artery disease, more precisely:
ACS PCI CABG The index event must be occurred between 15 days and 8 weeks preceding the enrollment
Inclusion Criteria:
- Patients must have a documented coronary artery disease, more precisely:
ACS PCI CABG The index event must be occurred between 15 days and 8 weeks preceding the enrollment.
- Written informed consent to participate to the study
Exclusion Criteria:
- Patients unwilling to give their written informed consent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520140
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heart Care Foundation |
| ClinicalTrials.gov Identifier: | NCT03520140 |
| Other Study ID Numbers: |
K18 |
| First Posted: | May 9, 2018 Key Record Dates |
| Last Update Posted: | October 9, 2020 |
| Last Verified: | April 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Familial hypercholesterolemia Coronary artery disease |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Hyperlipoproteinemia Type II Hypercholesterolemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |