Clinical trial NCT03883711: Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
Official title: Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Myocardium; Injury
Keywords: Acute coronary syndrome
Myocardial injury
ACS
MINOCA
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 11000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with a diagnosis of acute coronary syndrome or myocardial injury

Brief summary: 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.

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

Primary outcomes:
measure: All cause mortality
timeFrame: 1 year
measure: All cause mortality
timeFrame: 3 years
measure: All cause mortality
timeFrame: 5 years
measure: Major Adverse Cardiac Events (MACEs)
timeFrame: 1 year
measure: Major Adverse Cardiac Events (MACEs)
timeFrame: 3 years
measure: Major Adverse Cardiac Events (MACEs)
timeFrame: 5 years
Secondary outcomes:
measure: Cardiovascular risk factors prevalence
timeFrame: 1 year
measure: Cardiovascular risk factors prevalence
timeFrame: 3 year
measure: Cardiovascular risk factors prevalence
timeFrame: 5 year
measure: Differences in clinical presentation
timeFrame: 3 year
measure: Differences in clinical presentation
timeFrame: 1 year
measure: Differences in clinical presentation
timeFrame: 5 year
measure: Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury
timeFrame: 5 year
measure: Differences in flow characteristics
timeFrame: 1 year
measure: Differences in flow characteristics
timeFrame: 3 year
measure: Differences in flow characteristics
timeFrame: 5 year
measure: Differences and impact of periprocedural ischemic complications
timeFrame: 5 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi, Cardiology Department
Study officials:
affiliation: University of Bologna, Cardiology Department
name: Carmine Pizzi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38). Circulation. 2012 Jan 31;125(4):577-83. doi: 10.1161/CIRCULATIONAHA.111.041160. Epub 2011 Dec 23.
citation: 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.
citation: 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.
citation: 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 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
citation: 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.