Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

Acute Coronary Syndrome Clinical Trial

— AMIPE  

Official title:

Acute Myocardial Infarction From Clinical Presentation to Strategy Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883711
• Other study ID #: 600/2018/Oss/AOUBo
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Carmine Pizzi, Dr
• Phone: 0039 (0)512144933
• Email: carmine.pizzi[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Myocardium; Injury

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola-Malpighi, Cardiology Department	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Circulation. 2018 Nov 13;138(20):e652. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Death rate	1 year
Primary	All cause mortality	Death rate	3 years
Primary	All cause mortality	Death rate	5 years
Primary	Major Adverse Cardiac Events (MACEs)	MACEs rate	1 year
Primary	Major Adverse Cardiac Events (MACEs)	MACEs rate	3 years
Primary	Major Adverse Cardiac Events (MACEs)	MACEs rate	5 years
Secondary	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	1 year
Secondary	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	3 year
Secondary	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	5 year
Secondary	Differences in clinical presentation	Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)	3 year
Secondary	Differences in clinical presentation	Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)	1 year
Secondary	Differences in clinical presentation	Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)	5 year
Secondary	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)	5 year
Secondary	Differences in flow characteristics	TIMI, TIMI frame count	1 year
Secondary	Differences in flow characteristics	TIMI, TIMI frame count	3 year
Secondary	Differences in flow characteristics	TIMI, TIMI frame count	5 year
Secondary	Differences and impact of periprocedural ischemic complications	Type 4a myocardial infarction, periprocedural myocardial injury	5 year