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

October 7, 2020 updated by: Heart Care Foundation
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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

5415

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy
        • Istituto Scientifico Inrca - Uo Cardiologia/Utic/Telecardiologia
      • Ancona, Italy
        • Ospedali Riuniti - Sod Cardiologia Ospedaliera Emod. E Utic
      • Andria, Italy
        • Osp. Andria Canosa - Po Andria - Cardiologia - Utic
      • Aosta, Italy
        • Ospedale Generale Regionale-Po U. Parini - U.O. Cardiologia E Cure Intensive Card.
      • Arzignano, Italy
        • Ospedale Civile - U.O.C. Cardiologia
      • Ascoli Piceno, Italy
        • Ospedale Gen.Le Prov.Le C.G. Mazzoni - Sc Cardiologia
      • Augusta, Italy
        • Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
      • Aversa, Italy
        • Presidio Ospedaliero Moscati - U.O.C. Cardiologia
      • Bari, Italy
        • Ospedale Policlinico - U.O. Cardiologia Universitaria
      • Bari, Italy
        • Ospedale San Paolo - Cardiologia-Utic
      • Benevento, Italy
        • Azienda Ospedaliera G. Rummo - Cardiologia Interventistica E Utic
      • Bologna, Italy
        • Ospedale Maggiore - U.O. Di Cardiologia
      • Bolzano, Italy
        • Ospedale Generale Regionale - Ospedale Generale Regionale Divisione Di Cardiologia
      • Borgomanero, Italy
        • Ospedale Ss. Trinita' - S.C. Di Cardiologia
      • Cagliari, Italy
        • Azienda Ospedaliera G. Brotzu - Struttura Complessa Di Cardiologia
      • Cagliari, Italy
        • Ospedale San Giovanni Di Dio - Clinica Cardiologica
      • Campobasso, Italy
        • Ospedale A. Cardarelli - U.O. Cardiologia E Utic
      • Casarano, Italy
        • Presidio Ospedaliero F. Ferrari - Cardiologia - Utic
      • Caserta, Italy
        • Az. Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia-Utic
      • Catania, Italy
        • P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
      • Cefalù, Italy
        • Fondazione G. Giglio - U.O. Cardiologia E Utic
      • Cinisello Balsamo, Italy
        • Ospedale Bassini - U.O. Cardiologia E Utic
      • Cittadella, Italy
        • Ospedale Di Cittadella - U.O. Cardiologia
      • Copertino, Italy
        • Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
      • Cortona, Italy
        • Ospedale Valdichiana Santa Margherita - Uos Cardiologia E Hdu
      • Cotignola, Italy
        • Maria Cecilia Hospital - U.O. Di Cardiologia
      • Cremona, Italy
        • Ospedale Di Cremona - Uo Di Cardiologia
      • Erice, Italy
        • Ospedale Civile Sant'Antonio Abate - U.O.C. Di Cardiologia E Utic
      • Fidenza, Italy
        • Ospedale Civile - U.O.C. Cardiologia - Utic
      • Firenze, Italy
        • Aou Careggi - Interventistica Cardiologica Strutturale
      • Firenze, Italy
        • Aou Careggi - Riabilitazione Cardiologica
      • Firenze, Italy
        • Ospedale Santa Maria Nuova - Hdu Cardiologica/Utic
      • Foggia, Italy
        • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
      • Forlì, Italy
        • Ospedale G.B. Morgagni - L. Pierantoni - U.O. Cardiologia
      • Genova, Italy
        • E.O. Ospedali Galliera - S. C. Cardiologia
      • Guastalla, Italy
        • Ospedale Civile - Sc Cardiologia Area Nord
      • Lecce, Italy
        • Citta' Di Lecce Hospital - U.O. Di Cardiologia
      • Lido Di Camaiore, Italy
        • Nuovo Ospedale Versilia - Sc Cardiologia
      • Manduria, Italy
        • Ospedale Civile M. Giannuzzi - Cardiologia E Utic
      • Marsala, Italy
        • Presidio Ospedaliero Paolo Borsellino - U.O.C Cardiologia- Utic
      • Mercato San Severino, Italy
        • Ospedale G. Fucito - U.O. Di Cardiologia E Utic
      • Monza, Italy
        • Policlinico Di Monza - Uo Cardiol. Clinica E Scompenso Cardiaco
      • Napoli, Italy
        • Aorn Cardarelli - U.O. Cardiologia Con Utic
      • Napoli, Italy
        • Aorn Osp. Dei Colli- Po Vincenzo Monaldi - U.O.C. Cardiologia - S.U.N.
      • Novara, Italy
        • Aou Maggiore Della Carita' - Cardiologia Ii
      • Nuoro, Italy
        • Ospedale San Francesco - Cardiologia - Utic
      • Orbassano, Italy
        • Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
      • Palermo, Italy
        • Maria Eleonora Hospital - Cardiologia
      • Partinico, Italy
        • Ospedale Civico - U.O. Cardiologia
      • Pedara, Italy
        • Centro Cuore Morgagni - U.F. Utic Ed Emodinamica
      • Piedimonte Matese, Italy
        • Ospedale Civile Ave Gratia Plena - U.O. Di Cardiologia E Utic
      • Pistoia, Italy
        • Ospedale San Jacopo - U.O. Cardiologia
      • Pomezia, Italy
        • Policlinico Citta' Di Pomezia S. Anna - U.O. Cardiologia-Utic
      • Pozzuoli, Italy
        • Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
      • Reggio Emilia, Italy
        • Arcispedale Santa Maria Nuova - S.C. Cardiologia
      • Rimini, Italy
        • Ospedale Infermi - U.O. Cardiologia
      • Roma, 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
      • Salerno, Italy
        • A.O.U.S. Giovanni Di Dio-Ruggi D'Aragona - Sc Di Cardiologia
      • San Bonifacio, Italy
        • Ospedale G. Fracastoro - U.O.C. Di Cardiologia
      • San Giovanni Rotondo, Italy
        • Ospedale Casa Sollievo Della Sofferenza - Cardiologia - Utic - Riabil Cardiologica
      • Sanremo, Italy
        • Presidio Ospedaliero - U.O. Cardiologia
      • Santa Maria Capua Vetere, Italy
        • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
      • Saronno, Italy
        • Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
      • Scorrano, Italy
        • Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
      • Sesto San Giovanni, Italy
        • IRCCS Policlinico Multimedica - UO Cardiologia
      • Siracusa, Italy
        • Ospedale Umberto I - Uoc Cardiologia E Utic
      • Spoleto, Italy
        • Ospedale San Matteo Degli Infermi - Servizio Di Cardiologia Con Utic
      • Taranto, Italy
        • Casa Di Cura Villa Verde - Cardiologia
      • Termoli, Italy
        • Ospedale San Timoteo - Ssd Cardiologia Emodinamica
      • Thiene, Italy
        • Centro Polifunzionale Boldrini - Cardiologia Riabilitativa-Cardioaction
      • Torino, Italy
        • Aou Citta' Della Salute E Della Scienza-Scdu Cardiologia
      • Treviglio, Italy
        • Ospedali Treviglio-Caravaggio - Cardiologia
      • Trieste, Italy
        • Ospedali Riuniti - Osp. Maggiore - A.F. Cardiologia E Riabilitazione Cardio
      • Udine, Italy
        • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
      • Varese, Italy
        • Ospedale Di Circolo E Fondazione Macchi - Ssd Unita' Di Cure Intensive Coronariche
      • Vasto, Italy
        • Ospedale San Pio Da Pietrelcina - Cardiologia
      • Veruno, Italy
        • Ics Maugeri Spa Societa' Benefit - Uo Cardiologia Riabilitativa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Familial hypercholesterolemia diagnosis
Time Frame: Inclusion

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
Time Frame: Inclusion
Sequencing of (LDLR, APOB, PVSK9 and LDLRAP1)
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

Collaborators

Fondazione SISA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2016

Primary Completion (ACTUAL)

May 30, 2018

Study Completion (ACTUAL)

May 30, 2018

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 26, 2018

First Posted (ACTUAL)

May 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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