ClinicalTrials.gg
RecruitingNCT03883711AMIPEUpdated Jan 30, 2026

Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

An observational study in Acute Coronary Syndrome and Myocardium; Injury, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational

From the registry’s dates

  • Started Jan 2017; still recruiting 9 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
11,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Coronary Syndrome
  • Myocardium; Injury

Keywords

  • Acute coronary syndrome
  • Myocardial injury
  • ACS
  • MINOCA
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 11,000 is above the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient aged > 18 years old
  • Acute coronary syndrome or myocardial injury
  • Written

Exclusion criteria

Exclusion Criteria:

  • under age or not able to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
11,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with acute coronary syndrome or myocardial injury

    Incident consecutive patients presenting with acute coronary syndrome or myocardial injury

    Other: Database

Interventions

  • OtherDatabase

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

06

What researchers measure

Primary outcomes

  1. All cause mortality

    Death rate

    Time frame: 1 year

  2. All cause mortality

    Death rate

    Time frame: 3 years

  3. All cause mortality

    Death rate

    Time frame: 5 years

  4. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Time frame: 1 year

  5. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Time frame: 3 years

  6. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Time frame: 5 years

Secondary outcomes

  1. Cardiovascular risk factors prevalence

    Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors

    Time frame: 1 year

  2. Cardiovascular risk factors prevalence

    Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors

    Time frame: 3 year

  3. Cardiovascular risk factors prevalence

    Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors

    Time frame: 5 year

  4. Differences in clinical presentation

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

    Time frame: 3 year

  5. Differences in clinical presentation

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

    Time frame: 1 year

  6. Differences in clinical presentation

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

    Time frame: 5 year

  7. Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury

    Differences in clinical presentation (ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)

    Time frame: 5 year

  8. Differences in flow characteristics

    TIMI, TIMI frame count

    Time frame: 1 year

  9. Differences in flow characteristics

    TIMI, TIMI frame count

    Time frame: 3 year

  10. Differences in flow characteristics

    TIMI, TIMI frame count

    Time frame: 5 year

  11. Differences and impact of periprocedural ischemic complications

    Type 4a myocardial infarction, periprocedural myocardial injury

    Time frame: 5 year

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Bonaca MP, Wiviott SD, Braunwald E, Murphy SA, Ruff CT, Antman EM, Morrow DA. American College of Cardiology/American Heart Association/European Society of Cardiology/World Heart Federation universal definition of myocardial infarction classification system and the risk of cardiovascular death: observations from the TRITON-TIMI 38 trial (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38). Circulation. 2012 Jan 31;125(4):577-83. doi: 10.1161/CIRCULATIONAHA.111.041160. Epub 2011 Dec 23. PubMed 22199016 ↗
  • Sandoval Y, Smith SW, Sexter A, Thordsen SE, Bruen CA, Carlson MD, Dodd KW, Driver BE, Hu Y, Jacoby K, Johnson BK, Love SA, Moore JC, Schulz K, Scott NL, Apple FS. Type 1 and 2 Myocardial Infarction and Myocardial Injury: Clinical Transition to High-Sensitivity Cardiac Troponin I. Am J Med. 2017 Dec;130(12):1431-1439.e4. doi: 10.1016/j.amjmed.2017.05.049. Epub 2017 Jul 21. PubMed 28739197 ↗
  • Baron T, Hambraeus K, Sundstrom J, Erlinge D, Jernberg T, Lindahl B; TOTAL-AMI study group. Type 2 myocardial infarction in clinical practice. Heart. 2015 Jan;101(2):101-6. doi: 10.1136/heartjnl-2014-306093. Epub 2014 Oct 20. PubMed 25331532 ↗
  • Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available. PubMed 30571511 ↗
  • Canton L, Fedele D, Bergamaschi L, Foa A, Di Iuorio O, Tattilo FP, Rinaldi A, Angeli F, Armillotta M, Sansonetti A, Stefanizzi A, Amicone S, Impellizzeri A, Suma N, Bodega F, Cavallo D, Bertolini D, Ryabenko K, Casuso M, Belmonte M, Gallinoro E, Casella G, Galie N, Paolisso P, Pizzi C. Sex- and age-related differences in outcomes of patients with acute myocardial infarction: MINOCA vs. MIOCA. Eur Heart J Acute Cardiovasc Care. 2023 Sep 25;12(9):604-614. doi: 10.1093/ehjacc/zuad059. PubMed 37261384 ↗
  • Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6. PubMed 34560876 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03883711
Responsible party
Carmine Pizzi (Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna) — Principal investigator
First posted
Mar 21, 2019
Start date
Jan 1, 2017
Primary completion
Dec 31, 2024
Completion
Dec 31, 2028 (estimated)
Last update
Jan 30, 2026

Study contacts

Carmine Pizzi, Prof
Contact
carmine.pizzi@unibo.it
0039 (0)512144933
Carmine Pizzi, Dr
principal investigator · University of Bologna, Cardiology Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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