Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03520140
- Lead Sponsor
- Heart Care Foundation
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5415
- 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
- Patients unwilling to give their written informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genetic examination Inclusion Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)
Familial hypercholesterolemia diagnosis 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (81)
Ospedale Maggiore - U.O. Di Cardiologia
🇮🇹Bologna, Italy
Ospedale Ss. Trinita' - S.C. Di Cardiologia
🇮🇹Borgomanero, Italy
Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia
🇮🇹Cagliari, Italy
Presidio Ospedaliero F. Ferrari - Cardiologia - Utic
🇮🇹Casarano, Italy
Ospedale Civile - Sc Cardiologia Area Nord
🇮🇹Guastalla, Italy
Presidio Ospedaliero Paolo Borsellino - U.O.C Cardiologia- Utic
🇮🇹Marsala, Italy
Aorn Cardarelli - U.O. Cardiologia Con Utic
🇮🇹Napoli, Italy
Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia - S.U.N.
🇮🇹Napoli, Italy
Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic
🇮🇹Pomezia, Italy
Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
🇮🇹Pozzuoli, Italy
Ospedale Umberto I - Uoc Cardiologia E Utic
🇮🇹Siracusa, Italy
Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction
🇮🇹Thiene, Italy
Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche
🇮🇹Varese, Italy
Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa
🇮🇹Veruno, Italy
Ospedale Policlinico - U.O. Cardiologia Universitaria
🇮🇹Bari, Italy
Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic
🇮🇹Benevento, Italy
Ospedale Generale Regionale-Po U. Parini - U.O. Cardiologia E Cure Intensive Card.
🇮🇹Aosta, Italy
Ospedale Civile - U.O.C. Cardiologia
🇮🇹Arzignano, Italy
Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia
🇮🇹Bolzano, Italy
Ospedale A. Cardarelli - U.O. Cardiologia E Utic
🇮🇹Campobasso, Italy
Fondazione G. Giglio - U.O. Cardiologia E Utic
🇮🇹Cefalù, Italy
Ospedale Di Cremona - Uo Di Cardiologia
🇮🇹Cremona, Italy
Aou Careggi - Riabilitazione Cardiologica
🇮🇹Firenze, Italy
E.O. Ospedali Galliera - S. C. Cardiologia
🇮🇹Genova, Italy
Aou Maggiore Della Carita' - Cardiologia Ii
🇮🇹Novara, Italy
Presidio Ospedaliero - U.O. Cardiologia
🇮🇹Sanremo, Italy
Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
🇮🇹Saronno, Italy
IRCCS Policlinico Multimedica - UO Cardiologia
🇮🇹Sesto San Giovanni, Italy
Ospedali Riuniti - Osp. Maggiore - A.F. Cardiologia E Riabilitazione Cardio
🇮🇹Trieste, Italy
Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
🇮🇹Udine, Italy
Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
🇮🇹Augusta, Italy
Osp. Andria Canosa - Po Andria - Cardiologia - Utic
🇮🇹Andria, Italy
Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia
🇮🇹Ascoli Piceno, Italy
Ospedale San Giovanni Di Dio - Clinica Cardiologica
🇮🇹Cagliari, Italy
Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic
🇮🇹Caserta, Italy
Ospedale Bassini - U.O. Cardiologia E Utic
🇮🇹Cinisello Balsamo, Italy
Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu
🇮🇹Cortona, Italy
Citta' Di Lecce Hospital - U.O. Di Cardiologia
🇮🇹Lecce, Italy
Nuovo Ospedale Versilia - Sc Cardiologia
🇮🇹Lido Di Camaiore, Italy
Ospedale Civile M. Giannuzzi - Cardiologia E Utic
🇮🇹Manduria, Italy
Ospedale San Francesco - Cardiologia - Utic
🇮🇹Nuoro, Italy
Ospedale Civico - U.O. Cardiologia
🇮🇹Partinico, Italy
Ospedale San Pio Da Pietrelcina - Cardiologia
🇮🇹Vasto, Italy
P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
🇮🇹Roma, Italy
Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia
🇮🇹Ancona, Italy
Ospedale Di Cittadella - U.O. Cardiologia
🇮🇹Cittadella, Italy
Ospedale Civile - U.O.C. Cardiologia - Utic
🇮🇹Fidenza, Italy
Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco
🇮🇹Monza, Italy
Ospedale Civile Ave Gratia Plena - U.O. Di Cardiologia E Utic
🇮🇹Piedimonte Matese, Italy
A.O.U.S. Giovanni Di Dio-Ruggi D'Aragona - Sc Di Cardiologia
🇮🇹Salerno, Italy
Ospedale G. Fracastoro - U.O.C. Di Cardiologia
🇮🇹San Bonifacio, Italy
Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
🇮🇹Santa Maria Capua Vetere, Italy
Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic
🇮🇹Spoleto, Italy
Casa Di Cura Villa Verde - Cardiologia
🇮🇹Taranto, Italy
Presidio Ospedaliero Moscati - U.O.C. Cardiologia
🇮🇹Aversa, Italy
Campus Biomedico - Cardiologia
🇮🇹Roma, Italy
Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia
🇮🇹Roma, Italy
Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic
🇮🇹Ancona, Italy
Ospedale San Paolo - Cardiologia-Utic
🇮🇹Bari, Italy
P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
🇮🇹Catania, Italy
Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
🇮🇹Copertino, Italy
Ospedale Civile Sant'Antonio Abate - U.O.C. Di Cardiologia E Utic
🇮🇹Erice, Italy
Aou Careggi - Interventistica Cardiologica Strutturale
🇮🇹Firenze, Italy
Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic
🇮🇹Firenze, Italy
Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
🇮🇹Foggia, Italy
Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia
🇮🇹Forlì, Italy
Ospedale G. Fucito - U.O. Di Cardiologia E Utic
🇮🇹Mercato San Severino, Italy
Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
🇮🇹Orbassano, Italy
Maria Eleonora Hospital - Cardiologia
🇮🇹Palermo, Italy
Centro Cuore Morgagni - U.F. Utic Ed Emodinamica
🇮🇹Pedara, Italy
Ospedale San Jacopo - U.O. Cardiologia
🇮🇹Pistoia, Italy
Arcispedale Santa Maria Nuova - S.C. Cardiologia
🇮🇹Reggio Emilia, Italy
Ospedale Infermi - U.O. Cardiologia
🇮🇹Rimini, Italy
Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica
🇮🇹San Giovanni Rotondo, Italy
Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
🇮🇹Scorrano, Italy
Ospedale San Timoteo - Ssd Cardiologia Emodinamica
🇮🇹Termoli, Italy
Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia
🇮🇹Torino, Italy
Ospedali Treviglio-Caravaggio - Cardiologia
🇮🇹Treviglio, Italy
Policlinico Casilino - U.O. Cardiologia
🇮🇹Roma, Italy
Maria Cecilia Hospital - U.O. Di Cardiologia
🇮🇹Cotignola, Italy
Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia
🇮🇹Roma, Italy