AMIPE: Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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;
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document the long term outcome rates;
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with acute coronary syndrome or myocardial injury Incident consecutive patients presenting with acute coronary syndrome or myocardial injury |
Other: Database
Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.
|
Outcome Measures
Primary Outcome Measures
- All cause mortality [1 year]
Death rate
- All cause mortality [3 years]
Death rate
- All cause mortality [5 years]
Death rate
- Major Adverse Cardiac Events (MACEs) [1 year]
MACEs rate
- Major Adverse Cardiac Events (MACEs) [3 years]
MACEs rate
- Major Adverse Cardiac Events (MACEs) [5 years]
MACEs rate
Secondary Outcome Measures
- Cardiovascular risk factors prevalence [1 year]
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
- Cardiovascular risk factors prevalence [3 year]
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
- Cardiovascular risk factors prevalence [5 year]
Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
- Differences in clinical presentation [3 year]
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
- Differences in clinical presentation [1 year]
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
- Differences in clinical presentation [5 year]
Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
- Difference diagnosis between myocardial infarction subtypes and between myocardial infarction and myocardial injury [5 year]
Differences in clinical presentation (ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias)
- Differences in flow characteristics [1 year]
TIMI, TIMI frame count
- Differences in flow characteristics [3 year]
TIMI, TIMI frame count
- Differences in flow characteristics [5 year]
TIMI, TIMI frame count
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged > 18 years old
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Acute coronary syndrome or myocardial injury
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Written informed consent
Exclusion Criteria:
- under age or not able to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Policlinico Sant'Orsola-Malpighi, Cardiology Department | Bologna | Italy | 40138 |
Sponsors and Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Investigators
- Principal Investigator: Carmine Pizzi, Dr, University of Bologna, Cardiology Department
Study Documents (Full-Text)
None provided.More Information
Publications
- Baron T, Hambraeus K, Sundström 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.
- 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.
- 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.
- 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. Erratum in: Circulation. 2018 Nov 13;138(20):e652.
- 600/2018/Oss/AOUBo