Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Database.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndrome, Myocardium; Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment
Overview
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.
Detailed description
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.
Interventions
- Other Database
Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.
Primary outcome measures
- All cause mortality [Time frame: 1 year]
- All cause mortality [Time frame: 3 years]
- All cause mortality [Time frame: 5 years]
- Major Adverse Cardiac Events (MACEs) [Time frame: 1 year]
- Major Adverse Cardiac Events (MACEs) [Time frame: 3 years]
- Major Adverse Cardiac Events (MACEs) [Time frame: 5 years]
Secondary outcome measures (11)
- Cardiovascular risk factors prevalence [Time frame: 1 year]
- Cardiovascular risk factors prevalence [Time frame: 3 year]
- Cardiovascular risk factors prevalence [Time frame: 5 year]
- Differences in clinical presentation [Time frame: 3 year]
- Differences in clinical presentation [Time frame: 1 year]
- Differences in clinical presentation [Time frame: 5 year]
- Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury [Time frame: 5 year]
- Differences in flow characteristics [Time frame: 1 year]
- Differences in flow characteristics [Time frame: 3 year]
- Differences in flow characteristics [Time frame: 5 year]
- Differences and impact of periprocedural ischemic complications [Time frame: 5 year]
Eligibility criteria
Inclusion criteria
- Patient aged > 18 years old
- Acute coronary syndrome or myocardial injury
- Written informed consent
Exclusion criteria
- under age or not able to give informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- Policlinico Sant'Orsola-Malpighi, Cardiology Department — Bologna
- Ospedale Maggiore Carlo Alberto Pizzardi — Bologna
- Ospedale Morgagni - Pierantoni — Forlì
Publications
- 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
Identifiers
NCT: NCT03883711 · 600/2018/Oss/AOUBo