NCT03883711

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2017Dec 2028

Study Start

First participant enrolled

January 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

March 15, 2019

Last Update Submit

January 28, 2026

Conditions

Acute Coronary SyndromeMyocardium; Injury

Keywords

Acute coronary syndromeMyocardial injuryACSMINOCA

Outcome Measures

Primary Outcomes (6)

  • All cause mortality

    Death rate

    1 year

  • All cause mortality

    Death rate

    3 years

  • All cause mortality

    Death rate

    5 years

  • Major Adverse Cardiac Events (MACEs)

    MACEs rate

    1 year

  • Major Adverse Cardiac Events (MACEs)

    MACEs rate

    3 years

  • Major Adverse Cardiac Events (MACEs)

    MACEs rate

    5 years

Secondary Outcomes (11)

  • Cardiovascular risk factors prevalence

    1 year

  • Cardiovascular risk factors prevalence

    3 year

  • Cardiovascular risk factors prevalence

    5 year

  • Differences in clinical presentation

    3 year

  • Differences in clinical presentation

    1 year

  • +6 more secondary outcomes

Study Arms (1)

Patients with acute coronary syndrome or myocardial injury

Incident consecutive patients presenting with acute coronary syndrome or myocardial injury

Other: Database

Interventions

DatabaseOTHER

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

Patients with acute coronary syndrome or myocardial injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • under age or not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Policlinico Sant'Orsola-Malpighi, Cardiology Department

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale Maggiore Carlo Alberto Pizzardi

Bologna, BO, 40133, Italy

RECRUITING

Ospedale Morgagni - Pierantoni

Forlì, FC, 47121, Italy

RECRUITING

Related Publications (6)

  • 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.

    PMID: 22199016BACKGROUND

  • 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.

    PMID: 28739197BACKGROUND

  • 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.

    PMID: 25331532BACKGROUND

  • 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.

    PMID: 30571511BACKGROUND

  • 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.

    PMID: 37261384DERIVED

  • 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.

    PMID: 34560876DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeWounds and InjuriesMINOCA

Interventions

Database Management Systems

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Management Information SystemsOrganization and AdministrationHealth Services Administration

Study Officials

  • Carmine Pizzi, Dr

    University of Bologna, Cardiology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmine Pizzi, Prof

CONTACT

0039 (0)512144933carmine.pizzi@unibo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 21, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

IT(3)