NCT03520140

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

81 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

October 9, 2020

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

April 13, 2018

Last Update Submit

October 7, 2020

Conditions

Keywords

Familial hypercholesterolemiaCoronary artery disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • Genetic examination

    Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)

    Inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients unwilling to give their written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (81)

Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia

Ancona, Italy

Location

Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic

Ancona, Italy

Location

Osp. Andria Canosa - Po Andria - Cardiologia - Utic

Andria, Italy

Location

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

Aosta, Italy

Location

Ospedale Civile - U.O.C. Cardiologia

Arzignano, Italy

Location

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

Ascoli Piceno, Italy

Location

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

Augusta, Italy

Location

Presidio Ospedaliero Moscati - U.O.C. Cardiologia

Aversa, Italy

Location

Ospedale Policlinico - U.O. Cardiologia Universitaria

Bari, Italy

Location

Ospedale San Paolo - Cardiologia-Utic

Bari, Italy

Location

Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic

Benevento, Italy

Location

Ospedale Maggiore - U.O. Di Cardiologia

Bologna, Italy

Location

Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia

Bolzano, Italy

Location

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

Borgomanero, Italy

Location

Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia

Cagliari, Italy

Location

Ospedale San Giovanni Di Dio - Clinica Cardiologica

Cagliari, Italy

Location

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

Campobasso, Italy

Location

Presidio Ospedaliero F. Ferrari - Cardiologia - Utic

Casarano, Italy

Location

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

Caserta, Italy

Location

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

Catania, Italy

Location

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

CefalĂ¹, Italy

Location

Ospedale Bassini - U.O. Cardiologia E Utic

Cinisello Balsamo, Italy

Location

Ospedale Di Cittadella - U.O. Cardiologia

Cittadella, Italy

Location

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

Copertino, Italy

Location

Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu

Cortona, Italy

Location

Maria Cecilia Hospital - U.O. Di Cardiologia

Cotignola, Italy

Location

Ospedale Di Cremona - Uo Di Cardiologia

Cremona, Italy

Location

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

Erice, Italy

Location

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

Fidenza, Italy

Location

Aou Careggi - Interventistica Cardiologica Strutturale

Florence, Italy

Location

Aou Careggi - Riabilitazione Cardiologica

Florence, Italy

Location

Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic

Florence, Italy

Location

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

Foggia, Italy

Location

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

Forlì, Italy

Location

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

Genova, Italy

Location

Ospedale Civile - Sc Cardiologia Area Nord

Guastalla, Italy

Location

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

Lecce, Italy

Location

Nuovo Ospedale Versilia - Sc Cardiologia

Lido di Camaiore, Italy

Location

Ospedale Civile M. Giannuzzi - Cardiologia E Utic

Manduria, Italy

Location

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

Marsala, Italy

Location

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

Mercato San Severino, Italy

Location

Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco

Monza, Italy

Location

Aorn Cardarelli - U.O. Cardiologia Con Utic

Napoli, Italy

Location

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

Napoli, Italy

Location

Aou Maggiore Della Carita' - Cardiologia Ii

Novara, Italy

Location

Ospedale San Francesco - Cardiologia - Utic

Nuoro, Italy

Location

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

Orbassano, Italy

Location

Maria Eleonora Hospital - Cardiologia

Palermo, Italy

Location

Ospedale Civico - U.O. Cardiologia

Partinico, Italy

Location

Centro Cuore Morgagni - U.F. Utic Ed Emodinamica

Pedara, Italy

Location

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

Piedimonte Matese, Italy

Location

Ospedale San Jacopo - U.O. Cardiologia

Pistoia, Italy

Location

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

Pomezia, Italy

Location

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

Pozzuoli, Italy

Location

Arcispedale Santa Maria Nuova - S.C. Cardiologia

Reggio Emilia, Italy

Location

Ospedale Infermi - U.O. Cardiologia

Rimini, Italy

Location

Campus Biomedico - Cardiologia

Roma, Italy

Location

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

Roma, Italy

Location

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

Roma, Italy

Location

Policlinico Casilino - U.O. Cardiologia

Roma, Italy

Location

Policlinico Umberto Primo - Cardiologia B - Cardiologia E Angiologia

Roma, Italy

Location

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

Salerno, Italy

Location

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

San Bonifacio, Italy

Location

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

San Giovanni Rotondo, Italy

Location

Presidio Ospedaliero - U.O. Cardiologia

Sanremo, Italy

Location

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

Santa Maria Capua Vetere, Italy

Location

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

Saronno, Italy

Location

Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic

Scorrano, Italy

Location

IRCCS Policlinico Multimedica - UO Cardiologia

Sesto San Giovanni, Italy

Location

Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic

Spoleto, Italy

Location

Ospedale Umberto I - Uoc Cardiologia E Utic

Syracuse, Italy

Location

Casa Di Cura Villa Verde - Cardiologia

Taranto, Italy

Location

Ospedale San Timoteo - Ssd Cardiologia Emodinamica

Termoli, Italy

Location

Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction

Thiene, Italy

Location

Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia

Torino, Italy

Location

Ospedali Treviglio-Caravaggio - Cardiologia

Treviglio, Italy

Location

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

Trieste, Italy

Location

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

Udine, Italy

Location

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

Varese, Italy

Location

Ospedale San Pio Da Pietrelcina - Cardiologia

Vasto, Italy

Location

Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa

Veruno, Italy

Location

Related Publications (2)

  • 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.

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Full gene sequencing of the genes involved in FH (LDLR, APOB, PVSK9 and LDLRAP1)

MeSH Terms

Conditions

Coronary Artery DiseaseHyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

May 9, 2018

Study Start

June 15, 2016

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

October 9, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations