European Unified Registries for Heart Care Evaluation and Randomised Trials Italy

Официальное название

European Unified Registries for Heart Care Evaluation and Randomised Trials

Обзор

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.

Вмешательства

• Другое Adherence to European Society of Cardiology (ESC) quality indicators
  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.

Первичные конечные точки

• Adherence to ESC Quality indicators (STEMI patients reperfused) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (STEMI patients reperfused <90 min) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (coronary angiography in NSTEMI patients within 24 hours) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (radial access) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (time to reperfusion in STEMI patients) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (pre-discharge LVEF evaluation in STEMI and NSTEMI patients) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (in hospital LDL-c evaluation in STEMI and NSTEMI patients) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (DAPT prescription at discharge in STEMI and NSTEMI patients) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (LLA prescription at discharge in STEMI and NSTEMI patients) [Срок оценки: From enrollment to 12 months follow-up]
• Adherence to ESC Quality indicators (ACEi/ARB/ARNI prescription at discharge in patients with LVEF ≤40%) [Срок оценки: From enrollment to 12 months follow-up]

Вторичные конечные точки (1)

• Cardiovascular and non-cardiovascular events during follow-up [Срок оценки: 12 months follow-up]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 57 центров

• Ospedale Valdarno S. Maria Della Gruccia - U.O. Malattie Cardiovascolari — Montevarchi
• Ospedale Miulli - U.O.C. Cardiologia - Utic — Acquaviva delle Fonti
• Ospedale Della Murgia - Fabio Perinei - S.C. Cardiologia-Utic — Altamura
• Ospedale San Paolo - Cardiologia-Utic — Bari
• Ospedale Di Venere - U.O.C. Di Cardiologia — Bari
• Asst Spedali Civili - Cardiologia — Brescia
• A.O.U. Cagliari Policlinico Monserrato - Sc Cardiologia Utic Emodinamica — Monserrato
• Azienda Ospedaliera Cannizzaro - Uoc Cardiologia — Catania
• … и ещё 49 центров

Публикации

• 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 PMID 33550362
• 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 Trial PMID 36243903
• 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/eha PMID 35443059
• 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 PMID 35380662
• 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
• 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

Идентификаторы

NCT: NCT07283809 · K27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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