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NCT Number: NCT03883711

Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maggiore Carlo Alberto Pizzardi, Bologna, BO, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Database

Other

Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.

Primary outcomes

  1. All cause mortality

    Time frame: 1 year

    Death rate

  2. All cause mortality

    Time frame: 3 years

    Death rate

  3. All cause mortality

    Time frame: 5 years

    Death rate

  4. Major Adverse Cardiac Events (MACEs)

    Time frame: 1 year

    MACEs rate

  5. Major Adverse Cardiac Events (MACEs)

    Time frame: 3 years

    MACEs rate

  6. Major Adverse Cardiac Events (MACEs)

    Time frame: 5 years

    MACEs rate

Secondary outcomes

  1. 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

  2. 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. 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

  4. Differences in clinical presentation

    Time frame: 3 year

    Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)

  5. Differences in clinical presentation

    Time frame: 1 year

    Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)

  6. Differences in clinical presentation

    Time frame: 5 year

    Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)

  7. 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)

  8. Differences in flow characteristics

    Time frame: 1 year

    TIMI, TIMI frame count

  9. Differences in flow characteristics

    Time frame: 3 year

    TIMI, TIMI frame count

  10. Differences in flow characteristics

    Time frame: 5 year

    TIMI, TIMI frame count

  11. Differences and impact of periprocedural ischemic complications

    Time frame: 5 year

    Type 4a myocardial infarction, periprocedural myocardial injury

Study contacts

Contact information is provided by the study sponsor or research team.

Carmine Pizzi, Prof

CONTACT

[email protected]

0039 (0)512144933

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment

Acronym: AMIPE

Important dates

Study start
2017
Primary completion
2024
Study completion
2028
First posted
Mar 21, 2019
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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