Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation (AMIPE)

October 4, 2023 updated by: Carmine Pizzi, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

11000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Policlinico Sant'Orsola-Malpighi, Cardiology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted with a diagnosis of acute coronary syndrome or myocardial injury

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute coronary syndrome or myocardial injury
Incident consecutive patients presenting with acute coronary syndrome or myocardial injury
Other: Database
Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 1 year
Death rate
1 year
All cause mortality
Time Frame: 3 years
Death rate
3 years
All cause mortality
Time Frame: 5 years
Death rate
5 years
Major Adverse Cardiac Events (MACEs)
Time Frame: 1 year
MACEs rate
1 year
Major Adverse Cardiac Events (MACEs)
Time Frame: 3 years
MACEs rate
3 years
Major Adverse Cardiac Events (MACEs)
Time Frame: 5 years
MACEs rate
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk factors prevalence
Time Frame: 1 year
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
1 year
Cardiovascular risk factors prevalence
Time Frame: 3 year
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
3 year
Cardiovascular risk factors prevalence
Time Frame: 5 year
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
5 year
Differences in clinical presentation
Time Frame: 3 year
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
3 year
Differences in clinical presentation
Time Frame: 1 year
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
1 year
Differences in clinical presentation
Time Frame: 5 year
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
5 year
Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury
Time Frame: 5 year
Differences in clinical presentation (ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
5 year
Differences in flow characteristics
Time Frame: 1 year
TIMI, TIMI frame count
1 year
Differences in flow characteristics
Time Frame: 3 year
TIMI, TIMI frame count
3 year
Differences in flow characteristics
Time Frame: 5 year
TIMI, TIMI frame count
5 year
Differences and impact of periprocedural ischemic complications
Time Frame: 5 year
Type 4a myocardial infarction, periprocedural myocardial injury
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Principal Investigator: Carmine Pizzi, Dr, University of Bologna, Cardiology Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 21, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 600/2018/Oss/AOUBo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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