Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

Официальное название

Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment

Обзор

AMIPE is both a retrospective and prospective study which was designed in order to collect data of patients with acute coronary syndromes and myocardial injury and to improve the knowledge about these conditions.

Подробное описание

AMIPE is an observational, multicenter and both retrospective and prospective study enrolling a cohort of consecutive incident patients admitted to participating hospitals with a diagnosis of acute coronary syndrome or myocardial injury from 01/01/2016 to 31/12/2023.

The aim of this study is to create a database including a comprehensive characterization of these patients in order to obtain new scientific evidence about these conditions. Informations about the patients will be gathered from in-hospital medical records. A written informed consent is needed for every prospective patients enrolled in the study,

In particular, the main objectives of the study are:

* document the characteristics of all patients presenting with acute coronary syndrome and myocardial injury; * document the long term outcome rates; * document the therapeutic regimens and investigation conformity of treatment with already established guidelines.

Every diagnostic or therapeutic intervention will be in accordance with established guidelines and good clinical practice.

Statistics will be conducted utilizing univariate and multivariate analysis for outcomes. In particular for what concerns univariate analysis, ordinal variables will be analysed with t-test and Mann-Whitney Test, whereas categorical responses with Fischer Exact Test and with Pearson Chi-square test.

Multivariate analysis will be conducted with logistic regression for dichotomous variables, with mixed generalized linear model for ordinal or nominal variables and with ANOVA or MANOVA for continuous variables.

Вмешательства

• Другое Database
  Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.

Первичные конечные точки

• All cause mortality [Срок оценки: 1 year]
• All cause mortality [Срок оценки: 3 years]
• All cause mortality [Срок оценки: 5 years]
• Major Adverse Cardiac Events (MACEs) [Срок оценки: 1 year]
• Major Adverse Cardiac Events (MACEs) [Срок оценки: 3 years]
• Major Adverse Cardiac Events (MACEs) [Срок оценки: 5 years]

Вторичные конечные точки (11)

• Cardiovascular risk factors prevalence [Срок оценки: 1 year]
• Cardiovascular risk factors prevalence [Срок оценки: 3 year]
• Cardiovascular risk factors prevalence [Срок оценки: 5 year]
• Differences in clinical presentation [Срок оценки: 3 year]
• Differences in clinical presentation [Срок оценки: 1 year]
• Differences in clinical presentation [Срок оценки: 5 year]
• Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury [Срок оценки: 5 year]
• Differences in flow characteristics [Срок оценки: 1 year]
• Differences in flow characteristics [Срок оценки: 3 year]
• Differences in flow characteristics [Срок оценки: 5 year]
• Differences and impact of periprocedural ischemic complications [Срок оценки: 5 year]

Критерии участия

Критерии включения

• Patient aged > 18 years old
• Acute coronary syndrome or myocardial injury
• Written informed consent

Критерии исключения

• under age or not able to give informed consent

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 · 3 центра

• Policlinico Sant'Orsola-Malpighi, Cardiology Department — Bologna
• Ospedale Maggiore Carlo Alberto Pizzardi — Bologna
• Ospedale Morgagni - Pierantoni — Forlì

Публикации

• Bonaca MP, Wiviott SD, Braunwald E, Murphy SA, Ruff CT, Antman EM, Morrow DA. American College of Cardiology/American Heart Association/European Society of Cardiology/World Heart Federation universal definition of myocardial infarction classification system and the risk of cardiovascular death: observations from the TRITON-TIMI 38 trial (Trial to Assess Improvement in Therapeutic Outcomes by Optim PMID 22199016
• Sandoval Y, Smith SW, Sexter A, Thordsen SE, Bruen CA, Carlson MD, Dodd KW, Driver BE, Hu Y, Jacoby K, Johnson BK, Love SA, Moore JC, Schulz K, Scott NL, Apple FS. Type 1 and 2 Myocardial Infarction and Myocardial Injury: Clinical Transition to High-Sensitivity Cardiac Troponin I. Am J Med. 2017 Dec;130(12):1431-1439.e4. doi: 10.1016/j.amjmed.2017.05.049. Epub 2017 Jul 21. PMID 28739197
• Baron T, Hambraeus K, Sundstrom J, Erlinge D, Jernberg T, Lindahl B; TOTAL-AMI study group. Type 2 myocardial infarction in clinical practice. Heart. 2015 Jan;101(2):101-6. doi: 10.1136/heartjnl-2014-306093. Epub 2014 Oct 20. PMID 25331532
• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 1 PMID 30571511
• Canton L, Fedele D, Bergamaschi L, Foa A, Di Iuorio O, Tattilo FP, Rinaldi A, Angeli F, Armillotta M, Sansonetti A, Stefanizzi A, Amicone S, Impellizzeri A, Suma N, Bodega F, Cavallo D, Bertolini D, Ryabenko K, Casuso M, Belmonte M, Gallinoro E, Casella G, Galie N, Paolisso P, Pizzi C. Sex- and age-related differences in outcomes of patients with acute myocardial infarction: MINOCA vs. MIOCA. Eur PMID 37261384
• Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6. PMID 34560876

Идентификаторы

NCT: NCT03883711 · 600/2018/Oss/AOUBo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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