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

Coronary Artery Disease Clinical Trial

— POSTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520140
• Other study ID #: K18
• Status: Completed
• Start date: June 15, 2016
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2018
• Source: Heart Care Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 5415
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia
• Hyperlipoproteinemia Type II
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	Aou Careggi - Riabilitazione Cardiologica	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	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 Umberto I - Uoc Cardiologia E Utic	Siracusa
Italy	Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic	Spoleto
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

Sponsors (2)

Lead Sponsor	Collaborator
Heart Care Foundation	Fondazione SISA

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 hyperc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Familial hypercholesterolemia diagnosis	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	Inclusion
Primary	Genetic examination	Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)	Inclusion