AzTrials
AzTrials

Acute Coronary SyndromeAMIPENCT03883711

Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

An observational study of Acute Coronary Syndrome and Myocardium; Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome, Myocardium; Injury
What is being tested?
Database
How many people
11,000 participants
Where
3 sitesItaly
Study dates
1 Jan 2017to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • under age or not able to give informed consent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carmine Pizzi, Prof contact

0039 (0)512144933

carmine.pizzi@unibo.it

Italy3 sites, 3 recruiting

  • Policlinico Sant'Orsola-Malpighi, Cardiology Department

    Bologna, Bologna, 40138

    Carmine Pizzi, Prof, 0039 (0)512144933, carmine.pizzi@unibo.it

    Recruiting

  • Ospedale Maggiore Carlo Alberto Pizzardi

    Bologna, BO, 40133

    Gianni Casella, MD, 051 6478111, gianni.casella@alice.it

    Recruiting

  • Ospedale Morgagni - Pierantoni

    Forlì, FC, 47121

    Miriam Compagnone, MD, 0543 738148, miriam.compagnone@auslromagna.it

    Recruiting

Other trials in Italy

About this study

Official title: 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.

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.

Being tested
Database
Keywords
Acute coronary syndrome, Myocardial injury, ACS, MINOCA
Medical subject headings
Acute Coronary Syndrome, Wounds and Injuries, MINOCA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DatabaseOther

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

Study groups in NCT03883711
Study groupRoleWhat they receive
Patients with acute coronary syndrome or myocardial injuryIncident consecutive patients presenting with acute coronary syndrome or myocardial injury
Receives: Other: Database

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause mortality

    Death rate

    Measured: 1 year

  2. All cause mortality

    Death rate

    Measured: 3 years

  3. All cause mortality

    Death rate

    Measured: 5 years

  4. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Measured: 1 year

  5. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Measured: 3 years

  6. Major Adverse Cardiac Events (MACEs)

    MACEs rate

    Measured: 5 years

Secondary outcomes (11)

  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

    Measured: 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

    Measured: 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

    Measured: 5 year

  4. Differences in clinical presentation

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

    Measured: 3 year

  5. Differences in clinical presentation

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

    Measured: 1 year

  6. Differences in clinical presentation

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

    Measured: 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)

    Measured: 5 year

  8. Differences in flow characteristics

    TIMI, TIMI frame count

    Measured: 1 year

  9. Differences in flow characteristics

    TIMI, TIMI frame count

    Measured: 3 year

  10. Differences in flow characteristics

    TIMI, TIMI frame count

    Measured: 5 year

  11. Differences and impact of periprocedural ischemic complications

    Type 4a myocardial infarction, periprocedural myocardial injury

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
11,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03883711
Sponsor's protocol ID
600/2018/Oss/AOUBo
Acronym
AMIPE
Status last verified
Jan 2026
First submitted
15 Mar 2019
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Myocardium; Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carmine Pizzi, Prof (0039 (0)512144933, carmine.pizzi@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause mortality (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03883711, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in