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Coronary Artery DiseasePOSTERNCT03520140

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

An observational study of Coronary Artery Disease, run by Heart Care Foundation at 81 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
5,415 participants
Where
81 sitesItaly
Study dates
15 Jun 2016to 30 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Patients unwilling to give their written informed consent.

Trial locations and contacts

81 sites in 1 country.

81 sites in 1 country

Italy81 sites

  • Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia

    Ancona

  • Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic

    Ancona

  • Osp. Andria Canosa - Po Andria - Cardiologia - Utic

    Andria

  • Ospedale Generale Regionale-Po U. Parini - U.O. Cardiologia E Cure Intensive Card.

    Aosta

  • Ospedale Civile - U.O.C. Cardiologia

    Arzignano

  • Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia

    Ascoli Piceno

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

    Augusta

  • Presidio Ospedaliero Moscati - U.O.C. Cardiologia

    Aversa

  • Ospedale Policlinico - U.O. Cardiologia Universitaria

    Bari

  • Ospedale San Paolo - Cardiologia-Utic

    Bari

  • Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic

    Benevento

  • Ospedale Maggiore - U.O. Di Cardiologia

    Bologna

  • Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia

    Bolzano

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

    Borgomanero

  • Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia

    Cagliari

  • Ospedale San Giovanni Di Dio - Clinica Cardiologica

    Cagliari

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

    Campobasso

  • Presidio Ospedaliero F. Ferrari - Cardiologia - Utic

    Casarano

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

    Caserta

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

    Catania

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

    Cefalù

  • Ospedale Bassini - U.O. Cardiologia E Utic

    Cinisello Balsamo

  • Ospedale Di Cittadella - U.O. Cardiologia

    Cittadella

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

    Copertino

  • Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu

    Cortona

  • Maria Cecilia Hospital - U.O. Di Cardiologia

    Cotignola

  • Ospedale Di Cremona - Uo Di Cardiologia

    Cremona

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

    Erice

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

    Fidenza

  • Aou Careggi - Interventistica Cardiologica Strutturale

    Florence

  • Aou Careggi - Riabilitazione Cardiologica

    Florence

  • Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic

    Florence

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

    Foggia

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

    Forlì

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

    Genova

  • Ospedale Civile - Sc Cardiologia Area Nord

    Guastalla

  • Citta' Di Lecce Hospital - U.O. Di Cardiologia

    Lecce

  • Nuovo Ospedale Versilia - Sc Cardiologia

    Lido di Camaiore

  • Ospedale Civile M. Giannuzzi - Cardiologia E Utic

    Manduria

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

    Marsala

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

    Mercato San Severino

  • Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco

    Monza

  • Aorn Cardarelli - U.O. Cardiologia Con Utic

    Naples

  • Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia - S.U.N.

    Naples

  • Aou Maggiore Della Carita' - Cardiologia Ii

    Novara

  • Ospedale San Francesco - Cardiologia - Utic

    Nuoro

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

    Orbassano

  • Maria Eleonora Hospital - Cardiologia

    Palermo

  • Ospedale Civico - U.O. Cardiologia

    Partinico

  • Centro Cuore Morgagni - U.F. Utic Ed Emodinamica

    Pedara

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

    Piedimonte Matese

  • Ospedale San Jacopo - U.O. Cardiologia

    Pistoia

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

    Pomezia

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

    Pozzuoli

  • Arcispedale Santa Maria Nuova - S.C. Cardiologia

    Reggio Emilia

  • Ospedale Infermi - U.O. Cardiologia

    Rimini

  • Campus Biomedico - Cardiologia

    Roma

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

    Roma

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

    Roma

  • Policlinico Casilino - U.O. Cardiologia

    Roma

  • Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia

    Roma

  • A.O.U.S. Giovanni Di Dio-Ruggi D'Aragona - Sc Di Cardiologia

    Salerno

  • Ospedale G. Fracastoro - U.O.C. Di Cardiologia

    San Bonifacio

  • Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica

    San Giovanni Rotondo

  • Presidio Ospedaliero - U.O. Cardiologia

    Sanremo

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

    Santa Maria Capua Vetere

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

    Saronno

  • Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

    Scorrano

  • IRCCS Policlinico Multimedica - UO Cardiologia

    Sesto San Giovanni

  • Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic

    Spoleto

  • Ospedale Umberto I - Uoc Cardiologia E Utic

    Syracuse

  • Casa Di Cura Villa Verde - Cardiologia

    Taranto

  • Ospedale San Timoteo - Ssd Cardiologia Emodinamica

    Termoli

  • Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction

    Thiene

  • Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia

    Torino

  • Ospedali Treviglio-Caravaggio - Cardiologia

    Treviglio

  • Ospedali Riuniti - Osp. Maggiore - A.F. Cardiologia E Riabilitazione Cardio

    Trieste

  • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia

    Udine

  • Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche

    Varese

  • Ospedale San Pio Da Pietrelcina - Cardiologia

    Vasto

  • Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa

    Veruno

Other trials in Italy

About this study

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

Read the 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.

Keywords
Familial hypercholesterolemia, Coronary artery disease
Medical subject headings
Coronary Artery Disease, Hyperlipoproteinemia Type II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Inclusion

  2. Genetic examination

    Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)

    Measured: Inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2018
  2. Study start15 Jun 2016
  3. Primary completion30 May 2018
  4. Study completion30 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03520140
Sponsor's protocol ID
K18
Acronym
POSTER
Status last verified
Apr 2018
First submitted
13 Apr 2018
Last updated
9 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32823190

  • 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.

    PubMed 34617591

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Heart Care Foundation at 81 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Familial hypercholesterolemia diagnosis (time frame: Inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03520140, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.

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