Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

Recruiting

• Conditions: Acute Coronary Syndrome; Myocardium; Injury
• Interventions: Other: Database

• Registration Number: NCT03883711
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-21
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05
• Primary Completion: 2023-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with acute coronary syndrome or myocardial injury	Database	Incident consecutive patients presenting with acute coronary syndrome or myocardial injury

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACEs)	5 years	MACEs rate
All cause mortality	5 years	Death rate

Secondary Outcome Measures

Name	Time	Method
Differences in clinical presentation	5 year	Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
Cardiovascular risk factors prevalence	5 year	Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury	5 year	Differences in clinical presentation (ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
Differences and impact of periprocedural ischemic complications	5 year	Type 4a myocardial infarction, periprocedural myocardial injury
Differences in flow characteristics	5 year	TIMI, TIMI frame count

Trial Locations

Locations (1)

Policlinico Sant'Orsola-Malpighi, Cardiology Department; 🇮🇹 Bologna, Italy