Clinical trial NCT03520140: Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease
Official title: Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Familial hypercholesterolemia
Coronary artery disease
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
Collaborators: name: Fondazione SISA
First posted: 2018-05-09
Enrollment: 5415
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Familial hypercholesterolemia diagnosis
timeFrame: Inclusion
measure: Genetic examination
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia
city: Ancona
country: Italy
facility: Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic
city: Andria
country: Italy
facility: Osp. Andria Canosa - Po Andria - Cardiologia - Utic
city: Aosta
country: Italy
facility: Ospedale Generale Regionale-Po U. Parini - U.O. Cardiologia E Cure Intensive Card.
city: Arzignano
country: Italy
facility: Ospedale Civile - U.O.C. Cardiologia
city: Ascoli Piceno
country: Italy
facility: Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia
city: Augusta
country: Italy
facility: Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
city: Aversa
country: Italy
facility: Presidio Ospedaliero Moscati - U.O.C. Cardiologia
city: Bari
country: Italy
facility: Ospedale Policlinico - U.O. Cardiologia Universitaria
city: Bari
country: Italy
facility: Ospedale San Paolo - Cardiologia-Utic
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic
city: Bologna
country: Italy
facility: Ospedale Maggiore - U.O. Di Cardiologia
city: Bolzano
country: Italy
facility: Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia
city: Borgomanero
country: Italy
facility: Ospedale Ss. Trinita' - S.C. Di Cardiologia
city: Cagliari
country: Italy
facility: Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia
city: Cagliari
country: Italy
facility: Ospedale San Giovanni Di Dio - Clinica Cardiologica
city: Campobasso
country: Italy
facility: Ospedale A. Cardarelli - U.O. Cardiologia E Utic
city: Casarano
country: Italy
facility: Presidio Ospedaliero F. Ferrari - Cardiologia - Utic
city: Caserta
country: Italy
facility: Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic
city: Catania
country: Italy
facility: P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
city: Cefalù
country: Italy
facility: Fondazione G. Giglio - U.O. Cardiologia E Utic
city: Cinisello Balsamo
country: Italy
facility: Ospedale Bassini - U.O. Cardiologia E Utic
city: Cittadella
country: Italy
facility: Ospedale Di Cittadella - U.O. Cardiologia
city: Copertino
country: Italy
facility: Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
city: Cortona
country: Italy
facility: Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital - U.O. Di Cardiologia
city: Cremona
country: Italy
facility: Ospedale Di Cremona - Uo Di Cardiologia
city: Erice
country: Italy
facility: Ospedale Civile Sant'Antonio Abate - U.O.C. Di Cardiologia E Utic
city: Fidenza
country: Italy
facility: Ospedale Civile - U.O.C. Cardiologia - Utic
city: Firenze
country: Italy
facility: Aou Careggi - Interventistica Cardiologica Strutturale
city: Firenze
country: Italy
facility: Aou Careggi - Riabilitazione Cardiologica
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic
city: Foggia
country: Italy
facility: Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
city: Forlì
country: Italy
facility: Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia
city: Genova
country: Italy
facility: E.O. Ospedali Galliera - S. C. Cardiologia
city: Guastalla
country: Italy
facility: Ospedale Civile - Sc Cardiologia Area Nord
city: Lecce
country: Italy
facility: Citta' Di Lecce Hospital - U.O. Di Cardiologia
city: Lido Di Camaiore
country: Italy
facility: Nuovo Ospedale Versilia - Sc Cardiologia
city: Manduria
country: Italy
facility: Ospedale Civile M. Giannuzzi - Cardiologia E Utic
city: Marsala
country: Italy
facility: Presidio Ospedaliero Paolo Borsellino - U.O.C Cardiologia- Utic
city: Mercato San Severino
country: Italy
facility: Ospedale G. Fucito - U.O. Di Cardiologia E Utic
city: Monza
country: Italy
facility: Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco
city: Napoli
country: Italy
facility: Aorn Cardarelli - U.O. Cardiologia Con Utic
city: Napoli
country: Italy
facility: Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia - S.U.N.
city: Novara
country: Italy
facility: Aou Maggiore Della Carita' - Cardiologia Ii
city: Nuoro
country: Italy
facility: Ospedale San Francesco - Cardiologia - Utic
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
city: Palermo
country: Italy
facility: Maria Eleonora Hospital - Cardiologia
city: Partinico
country: Italy
facility: Ospedale Civico - U.O. Cardiologia
city: Pedara
country: Italy
facility: Centro Cuore Morgagni - U.F. Utic Ed Emodinamica
city: Piedimonte Matese
country: Italy
facility: Ospedale Civile Ave Gratia Plena - U.O. Di Cardiologia E Utic
city: Pistoia
country: Italy
facility: Ospedale San Jacopo - U.O. Cardiologia
city: Pomezia
country: Italy
facility: Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova - S.C. Cardiologia
city: Rimini
country: Italy
facility: Ospedale Infermi - U.O. Cardiologia
city: Roma
country: Italy
facility: Campus Biomedico - Cardiologia
city: Roma
country: Italy
facility: Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia
city: Roma
country: Italy
facility: P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
city: Roma
country: Italy
facility: Policlinico Casilino - U.O. Cardiologia
city: Roma
country: Italy
facility: Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia
city: Salerno
country: Italy
facility: A.O.U.S. Giovanni Di Dio-Ruggi D'Aragona - Sc Di Cardiologia
city: San Bonifacio
country: Italy
facility: Ospedale G. Fracastoro - U.O.C. Di Cardiologia
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica
city: Sanremo
country: Italy
facility: Presidio Ospedaliero - U.O. Cardiologia
city: Santa Maria Capua Vetere
country: Italy
facility: Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
city: Saronno
country: Italy
facility: Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
city: Scorrano
country: Italy
facility: Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
city: Sesto San Giovanni
country: Italy
facility: IRCCS Policlinico Multimedica - UO Cardiologia
city: Siracusa
country: Italy
facility: Ospedale Umberto I - Uoc Cardiologia E Utic
city: Spoleto
country: Italy
facility: Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic
city: Taranto
country: Italy
facility: Casa Di Cura Villa Verde - Cardiologia
city: Termoli
country: Italy
facility: Ospedale San Timoteo - Ssd Cardiologia Emodinamica
city: Thiene
country: Italy
facility: Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction
city: Torino
country: Italy
facility: Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia
city: Treviglio
country: Italy
facility: Ospedali Treviglio-Caravaggio - Cardiologia
city: Trieste
country: Italy
facility: Ospedali Riuniti - Osp. Maggiore - A.F. Cardiologia E Riabilitazione Cardio
city: Udine
country: Italy
facility: Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche
city: Vasto
country: Italy
facility: Ospedale San Pio Da Pietrelcina - Cardiologia
city: Veruno
country: Italy
facility: Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa
Study officials:
References:
citation: Gulizia MM, Maggioni AP, Abrignani MG, Bilato C, Mangiacapra F, Sanchez FA, Piovaccari G, Montagna L, Marini M, De Biasio M, Averna M, Casula M, Colivicchi F, Fabbri G, Lucci D, Zampoleri V, Catapano AL; POSTER Investigators. Prevalence Of familial hypercholeSTerolaemia (FH) in Italian Patients with coronary artERy disease: The POSTER study. Atherosclerosis. 2020 Sep;308:32-38. doi: 10.1016/j.atherosclerosis.2020.07.007. Epub 2020 Jul 29.
citation: Qureshi N, Da Silva MLR, Abdul-Hamid H, Weng SF, Kai J, Leonardi-Bee J. Strategies for screening for familial hypercholesterolaemia in primary care and other community settings. Cochrane Database Syst Rev. 2021 Oct 7;10(10):CD012985. doi: 10.1002/14651858.CD012985.pub2.