European Unified Registries for Heart Care Evaluation and Randomised Trials Italy

NCT07283809 | Recruiting

• 1 other identifier: K27
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 57

Brief Summary

Major advances in cardiovascular medicine have been driven by innovations in basic research in biological and technical sciences. Despite the clear evidence regarding the treatments that have been demonstrated to be useful to improve patients' outcomes, their transferability to everyday clinical practice seems to be at least suboptimal. The European Society of Cardiology (ESC), therefore, planned to support a program, denominated EuroHeart, for continuous data collection of standardized and/or harmonized variables in common cardiovascular diseases, such as ACS, HF and A Fib. EuroHeart is an observational, prospective, multicentre initiative with continuous data collection in consecutive patients with ACS, HF and A Fib to support continuous quality of care improvement through the evaluation of quality indicators (QIs) defined by the ESC. All patients included in the EuroHeart initiative, will enter a 12 month longitudinal follow-up with the collection of clinical events and clinical status data.

Conditions

ACS - Acute Coronary Syndrome

Keywords

Quality indicators; ACS; STEMI; NSTEMI; ESC; Guidelines

Outcome Measures

Primary Outcomes (11)

• Adherence to ESC Quality indicators (STEMI patients reperfused)

  Proportion of patients with STEMI reperfused among those eligible (onset of symptoms to diagnosis \<12 hours)

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (STEMI patients reperfused <90 min)

  Proportion of patients with STEMI who receive timely reperfusion with PCI (wire crossing) within 90 minutes from initial diagnostic ECG

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (coronary angiography in NSTEMI patients within 24 hours)

  Rate of NSTEMI patients who receive invasive within 24 hours from their diagnosis

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (radial access)

  Use of radial access in case of invasive strategy for patients with STEMI and NSTEMI

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (time to reperfusion in STEMI patients)

  The time between the initial STEMI diagnosis and arterial access (absolute value) for primary PCI

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (pre-discharge LVEF evaluation in STEMI and NSTEMI patients)

  The proportion of patients with STEMI and NSTEMI who have an assessment of their left ventricular ejection fraction (LVEF) before hospital discharge

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (in hospital LDL-c evaluation in STEMI and NSTEMI patients)

  The proportion of patients with STEMI and NSTEMI who have their LDL cholesterol measured during hospitalization

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (DAPT prescription at discharge in STEMI and NSTEMI patients)

  Proportion of patients with STEMI and NSTEMI discharged on dual antiplatelet therapy

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (LLA prescription at discharge in STEMI and NSTEMI patients)

  Proportion of patients discharged from hospital on Lipid Lowering Agents (LLA)

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (ACEi/ARB/ARNI prescription at discharge in patients with LVEF ≤40%)

  Proportion of patients with LVEF ≤40% who are discharged from hospital on angiotensin converting enzymes inhibitors (ACEi) or angiotensin receptor blockers (ARBs) or angiotensin receptor-neprilysin inhibitor (ARNI)

  From enrollment to 12 months follow-up

• Adherence to ESC Quality indicators (Beta blockers prescription at discharge in patients with LVEF ≤40%)

  Proportion of patients with LVEF ≤40% who are discharged from hospital on beta blockers.

  From enrollment to 12 months follow-up

Secondary Outcomes (1)

• Cardiovascular and non-cardiovascular events during follow-up

  12 months follow-up

Interventions

Adherence to European Society of Cardiology (ESC) quality indicators OTHER

EuroHeart is an initiative of the European Society of Cardiology (ESC) supporting continuous quality-of-care improvement through individual patient data collection. The present registry component refers specifically to the Italian implementation of the EuroHeart programme, aimed at monitoring and improving adherence to ESC quality indicators within Italian clinical practice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with ACS

You may qualify if:

• Patients ≥18 years of age.
• Males and females at birth.
• At least one of the following clinical conditions:
• Hospitalization for Acute Coronary Syndrome (ACS)
• Heart failure (HF, outpatients, and/or inpatients)
• Atrial fibrillation (A Fib, outpatients and/or inpatients)
• Signed informed consent for the study and for privacy.

You may not qualify if:

• patients who do not sign the consent to participate in the project and/or Privacy

Sponsors & Collaborators

• Heart Care Foundation: lead

Study Sites (57)

Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari

Montevarchi, AREZZO, 52027, Italy

RECRUITING

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

Acquaviva delle Fonti, BA, 70021, Italy

RECRUITING

Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic

Altamura, BA, 70022, Italy

RECRUITING

Ospedale San Paolo - Cardiologia-Utic

Bari, BA, 70123, Italy

RECRUITING

Ospedale Di Venere - U.O.C. Di Cardiologia

Bari, BA, 70131, Italy

RECRUITING

Asst Spedali Civili - Cardiologia

Brescia, BS, 25123, Italy

RECRUITING

A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica

Monserrato, CAGLIARI, 09124, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Cannizzaro - Uoc Cardiologia

Catania, CATANIA, 95126, Italy

RECRUITING

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

Campobasso, CB, 86100, Italy

RECRUITING

Azienda Ospedaliera S. Anna E S. Sebastiano - U.O. Cardiologia D'Emergenza Con Utic

Caserta, CE, 81100, Italy

RECRUITING

Casa Di Cura San Michele - Uo Cardiologia

Maddaloni, CE, 81024, Italy

RECRUITING

Ospedale Di Cremona - Uo Di Cardiologia

Cremona, CR, 26100, Italy

ACTIVE NOT RECRUITING

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

Castrovillari, CS, 87012, Italy

NOT YET RECRUITING

Ospedale Annunziata - Uoc Cardiologia

Cosenza, CS, 87100, Italy

RECRUITING

P.O. "Pugliese" - A.O.U. "Renato Dulbecco" - Utic-Emodinamica E Cardiologia Interventistica

Catanzaro, CZ, 88100, Italy

NOT YET RECRUITING

Policlinico Riuniti - S.C. Di Cardiologia Universitaria-Utic

Foggia, FG, 71100, Italy

RECRUITING

Ospedale San Giuseppe - Cardiologia

Empoli, FI, 50053, Italy

RECRUITING

Aou Careggi - Interventistica Cardiologica Strutturale

Florence, FI, 50134, Italy

ACTIVE NOT RECRUITING

Irccs Ospedale Policlinico San Martino - Unita' Operativa Cardiologia

Genova, GE, 16132, Italy

RECRUITING

Irccs Centro Neurolesi Bonino Pulejo - P.O. Piemonte - Cardiologia E Utic

Messina, MESSINA, 98124, Italy

RECRUITING

Policlinico G. Martino U.O.C - Cardiologia Con Utic

Messina, MESSINA, 98124, Italy

RECRUITING

Ospedale Civile Fornaroli - U.O. Cardiologia

Magenta, MILANO, 20013, Italy

RECRUITING

Irccs Ospedale San Raffaele - Area Unica Di Terapia Intensiva Cardiologica E Cch

Milan, MILANO, 20132, Italy

NOT YET RECRUITING

Ospedale L. Sacco - Sc Cardiologia

Milan, MILANO, 20157, Italy

ACTIVE NOT RECRUITING

Asst Ospedale Metropolitano Niguarda - Cardiologia 1 - Emodinamica

Milan, Mlano, 20162, Italy

ACTIVE NOT RECRUITING

Aou Federico Ii - Uoc Cardiologia Emodinamica Ed Utic

Naples, NAPOLI, 80131, Italy

RECRUITING

Aou Policlinico P. Giaccone - U.O.C. Cardiologia

Palermo, PALERMO, 90127, Italy

ACTIVE NOT RECRUITING

Aor Villa Sofia-Cervello Po Villa Sofia - Uoc Cardiologia E Utic E Emodinamica -Villa Sofia

Palermo, PALERMO, 90146, Italy

RECRUITING

Azienda Ospedale-Universita Padova - Uosd Terapia Intensiva Cardiologica

Padua, PD, 35128, Italy

ACTIVE NOT RECRUITING

Ospedale Civile Dello Spirito Santo - Cardiologia Con Utic

Pescara, PE, 65124, Italy

RECRUITING

Azienda Ospedaliera Di Perugia - S.C. Cardiologia

Perugia, PG, 06129, Italy

NOT YET RECRUITING

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

Fidenza, PR, 43036, Italy

RECRUITING

Presidio Ospedaliero San Salvatore - Cardiologia E Utic

Pesaro, PU, 61121, Italy

RECRUITING

Po Santa Maria Nuova - Ausl Re Irccs - Soc Cardiologia Ospedaliera

Reggio Emilia, RE, 42100, Italy

RECRUITING

Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic

Ragusa, RG, 97100, Italy

RECRUITING

P.O. San Camillo de Lellis - U.O.C. Cardiologia

Rieti, RIETI, 02100, Italy

RECRUITING

Campus Biomedico - Cardiologia

Roma, RM, 00128, Italy

NOT YET RECRUITING

P.O. San Filippo Neri - Asl Roma 1 - Cardiologia Intensiva Ed Interventistica

Roma, RM, 00135, Italy

NOT YET RECRUITING

Ospedale Sandro Pertini - Uoc Cardiologia - Utic

Roma, RM, 00157, Italy

NOT YET RECRUITING

Policlinico Casilino - U.O.C. Cardiologia

Roma, RM, 00169, Italy

NOT YET RECRUITING

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

Roma, RM, 00177, Italy

RECRUITING

Ospedale Santa Maria Della Misericordia - U.O.C. Cardiologia

Rovigo, RO, 45100, Italy

RECRUITING

Ospedale San Luca - U.O. Utic - Cardiologia

Vallo della Lucania, SA, 84078, Italy

RECRUITING

Aou Senese Ospedale S. Maria Alle Scotte - Cardiologia

Siena, SI, 53100, Italy

NOT YET RECRUITING

P.O. Levante - Ospedale San Paolo - S.C. Cardiologia Levante

Savona, SV, 17100, Italy

RECRUITING

Ospedale Civile - S.C. Cardiologia

Ivrea, TO, 10015, Italy

NOT YET RECRUITING

Aou Citta' Della Salute E Della Scienza - S.C. Cardiologia U

Torino, TO, 10126, Italy

RECRUITING

Ospedale Santa Maria Del Carmine - U.O. Cardiologia Ad Indirizzo Elettrofisiologia

Rovereto, TRENTO, 38068, Italy

RECRUITING

Ospedale Santa Chiara - Divisione Di Cardiologia

Trento, TRENTO, 38122, Italy

RECRUITING

Asugi - Ospedale Di Cattinara - S.C. Cardiologia

Trieste, TS, 34149, Italy

RECRUITING

Ospedale Ca' Foncello - U.O.C. Cardiologia

Treviso, TV, 31100, Italy

RECRUITING

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

Udine, UD, 33100, Italy

RECRUITING

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

Saronno, VARESE, 21047, Italy

NOT YET RECRUITING

Ospedale Civile - U.O.C. Di Cardiologia

Arzignano, VI, 36071, Italy

RECRUITING

Irccs Ospedale Sacro Cuore Don Calabria - U.O. Di Cardiologia

Negrar, VR, 37024, Italy

RECRUITING

Aoui Di Verona - U.O. Cardiologia

Verona, VR, 37126, Italy

ACTIVE NOT RECRUITING

Aou Maggiore Della Carita' - Ssvd Utic

Novara, 28100, Italy

RECRUITING

Related Publications (6)

• Schiele F, Aktaa S, Rossello X, Ahrens I, Claeys MJ, Collet JP, Fox KAA, Gale CP, Huber K, Iakobishvili Z, Keys A, Lambrinou E, Leonardi S, Lettino M, Masoudi FA, Price S, Quinn T, Swahn E, Thiele H, Timmis A, Tubaro M, Vrints CJM, Walker D, Bueno H; ESC Scientific Document Group; Halvorsen S, Jernberg T, Jortveit J, Blondal M, Ibanez B, Hassager C. 2020 Update of the quality indicators for acute myocardial infarction: a position paper of the Association for Acute Cardiovascular Care: the study group for quality indicators from the ACVC and the NSTE-ACS guideline group. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):224-233. doi: 10.1093/ehjacc/zuaa037.

  PMID: 33550362 BACKGROUND

• Batra G, Aktaa S, Camm AJ, Costa F, Di Biase L, Duncker D, Fauchier L, Fragakis N, Frost L, Hijazi Z, Juhlin T, Merino JL, Mont L, Nielsen JC, Oldgren J, Polewczyk A, Potpara T, Sacher F, Sommer P, Tilz R, Maggioni AP, Wallentin L, Casadei B, Gale CP. Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):609-620. doi: 10.1093/ehjqcco/qcac068.

  PMID: 36243903 BACKGROUND

• Aktaa S, Batra G, Cleland JGF, Coats A, Lund LH, McDonagh T, Rosano G, Seferovic P, Vasko P, Wallentin L, Maggioni AP, Casadei B, Gale CP; Heart Failure Association of the European Society of Cardiology. Data standards for heart failure: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). Eur Heart J. 2022 Jun 14;43(23):2185-2195. doi: 10.1093/eurheartj/ehac151.

  PMID: 35443059 BACKGROUND

• Association of Cardiovascular Nursing and Allied Professions (ACNAP); Association for Acute CardioVascular Care (ACVC); European Association of Percutaneous Cardiovascular Interventions (EAPCI); EURObservational Research Programme (EORP); ESC Patient Forum; ESC Working Group on Thrombosis and ESC Committee for Young Cardiovascular Professionals; Batra G, Aktaa S, Wallentin L, Maggioni AP, Ludman P, Erlinge D, Casadei B, Gale CP. Data standards for acute coronary syndrome and percutaneous coronary intervention: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). Eur Heart J. 2022 Jun 21;43(24):2269-2285. doi: 10.1093/eurheartj/ehac133.

  PMID: 35380662 BACKGROUND

• Aktaa S, Batra G, Wallentin L, Baigent C, Erlinge D, James S, Ludman P, Maggioni AP, Price S, Weston C, Casadei B, Gale CP. European Society of Cardiology methodology for the development of quality indicators for the quantification of cardiovascular care and outcomes. Eur Heart J Qual Care Clin Outcomes. 2022 Jan 5;8(1):4-13. doi: 10.1093/ehjqcco/qcaa069.

  PMID: 32845314 BACKGROUND

• Wallentin L, Gale CP, Maggioni A, Bardinet I, Casadei B. EuroHeart: European Unified Registries On Heart Care Evaluation and Randomized Trials. Eur Heart J. 2019 Sep 1;40(33):2745-2749. doi: 10.1093/eurheartj/ehz599. No abstract available.

  PMID: 31505603 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Furio Colivicchi, MD

CONTACT

055/51013741; euroheart.italia@heartcarefoundation.itON.IT

Aldo P Maggioni, MD

CONTACT

055/5101361; maggioni@heartcarefoundation.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: September 15, 2024
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (57)