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Clinical Trials/NCT03883711
NCT03883711
Recruiting
N/A

Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment

IRCCS Azienda Ospedaliero-Universitaria di Bologna3 sites in 1 country11,000 target enrollmentJanuary 1, 2017

Overview

Phase
N/A
Intervention
Database
Conditions
Acute Coronary Syndrome
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
11000
Locations
3
Primary Endpoint
Major Adverse Cardiac Events (MACEs)
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
December 31, 2028
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carmine Pizzi

Principal investigator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

Arms & Interventions

Patients with acute coronary syndrome or myocardial injury

Incident consecutive patients presenting with acute coronary syndrome or myocardial injury

Intervention: Database

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (MACEs)

Time Frame: 5 years

MACEs rate

All cause mortality

Time Frame: 5 years

Death rate

All cause mortality

Time Frame: 1 year

Death rate

All cause mortality

Time Frame: 3 years

Death rate

Major Adverse Cardiac Events (MACEs)

Time Frame: 1 year

MACEs rate

Major Adverse Cardiac Events (MACEs)

Time Frame: 3 years

MACEs rate

Secondary Outcomes

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

Study Sites (3)

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