Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease

NCT ID: NCT03520140

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5415 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2018-05-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione SISA

UNKNOWN

Sponsor Role: collaborator

Heart Care Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia

Ancona, , Italy

Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic

Ancona, , Italy

Osp. Andria Canosa - Po Andria - Cardiologia - Utic

Andria, , 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 Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia

Ascoli Piceno, , Italy

Ospedale E. Muscatello - U.O. Di Cardiologia - Utic

Augusta, , Italy

Presidio Ospedaliero Moscati - U.O.C. Cardiologia

Aversa, , Italy

Ospedale Policlinico - U.O. Cardiologia Universitaria

Bari, , Italy

Ospedale San Paolo - Cardiologia-Utic

Bari, , Italy

Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic

Benevento, , Italy

Ospedale Maggiore - U.O. Di Cardiologia

Bologna, , Italy

Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia

Bolzano, , Italy

Ospedale Ss. Trinita' - S.C. Di Cardiologia

Borgomanero, , Italy

Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia

Cagliari, , Italy

Ospedale San Giovanni Di Dio - Clinica Cardiologica

Cagliari, , Italy

Ospedale A. Cardarelli - U.O. Cardiologia E Utic

Campobasso, , Italy

Presidio Ospedaliero F. Ferrari - Cardiologia - Utic

Casarano, , Italy

Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic

Caserta, , Italy

P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia

Catania, , Italy

Fondazione G. Giglio - U.O. Cardiologia E Utic

Cefalù, , Italy

Ospedale Bassini - U.O. Cardiologia E Utic

Cinisello Balsamo, , Italy

Ospedale Di Cittadella - U.O. Cardiologia

Cittadella, , Italy

Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic

Copertino, , Italy

Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu

Cortona, , Italy

Maria Cecilia Hospital - U.O. Di Cardiologia

Cotignola, , Italy

Ospedale Di Cremona - Uo Di Cardiologia

Cremona, , Italy

Ospedale Civile Sant'Antonio Abate - U.O.C. Di Cardiologia E Utic

Erice, , Italy

Ospedale Civile - U.O.C. Cardiologia - Utic

Fidenza, , Italy

Aou Careggi - Interventistica Cardiologica Strutturale

Florence, , Italy

Aou Careggi - Riabilitazione Cardiologica

Florence, , Italy

Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic

Florence, , Italy

Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic

Foggia, , Italy

Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia

Forlì, , Italy

E.O. Ospedali Galliera - S. C. Cardiologia

Genova, , Italy

Ospedale Civile - Sc Cardiologia Area Nord

Guastalla, , 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

Presidio Ospedaliero Paolo Borsellino - U.O.C Cardiologia- Utic

Marsala, , Italy

Ospedale G. Fucito - U.O. Di Cardiologia E Utic

Mercato San Severino, , Italy

Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco

Monza, , 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

Aou Maggiore Della Carita' - Cardiologia Ii

Novara, , Italy

Ospedale San Francesco - Cardiologia - Utic

Nuoro, , Italy

Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia

Orbassano, , Italy

Maria Eleonora Hospital - Cardiologia

Palermo, , Italy

Ospedale Civico - U.O. Cardiologia

Partinico, , Italy

Centro Cuore Morgagni - U.F. Utic Ed Emodinamica

Pedara, , Italy

Ospedale Civile Ave Gratia Plena - U.O. Di Cardiologia E Utic

Piedimonte Matese, , Italy

Ospedale San Jacopo - U.O. Cardiologia

Pistoia, , Italy

Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic

Pomezia, , Italy

Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic

Pozzuoli, , Italy

Arcispedale Santa Maria Nuova - S.C. Cardiologia

Reggio Emilia, , Italy

Ospedale Infermi - U.O. Cardiologia

Rimini, , Italy

Campus Biomedico - Cardiologia

Roma, , Italy

Ospedale Madre Giuseppina Vannini - U.O.C. Cardiologia

Roma, , Italy

P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic

Roma, , Italy

Policlinico Casilino - U.O. Cardiologia

Roma, , Italy

Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia

Roma, , 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 Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica

San Giovanni Rotondo, , Italy

Presidio Ospedaliero - U.O. Cardiologia

Sanremo, , Italy

Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic

Santa Maria Capua Vetere, , Italy

Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia

Saronno, , Italy

Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

Scorrano, , Italy

IRCCS Policlinico Multimedica - UO Cardiologia

Sesto San Giovanni, , Italy

Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic

Spoleto, , Italy

Ospedale Umberto I - Uoc Cardiologia E Utic

Syracuse, , Italy

Casa Di Cura Villa Verde - Cardiologia

Taranto, , Italy

Ospedale San Timoteo - Ssd Cardiologia Emodinamica

Termoli, , Italy

Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction

Thiene, , Italy

Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia

Torino, , Italy

Ospedali Treviglio-Caravaggio - Cardiologia

Treviglio, , 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 Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche

Varese, , Italy

Ospedale San Pio Da Pietrelcina - Cardiologia

Vasto, , Italy

Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa

Veruno, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 32823190 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34617591 (View on PubMed)

Other Identifiers

K18

Identifier Type: -

Identifier Source: org_study_id