Ignite Creation Date:
2024-05-06 @ 12:55 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03883711
Status:
RECRUITING
Last Update Posted:
2023-10-05
First Post:
2019-03-15
Brief Title:
Acute Myocardial Infarction Prognostic and Therapeutic Evaluation
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMIPE
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 01012016 to 31122023
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None