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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with acute coronary syndrome or myocardial injury | Incident consecutive patients presenting with acute coronary syndrome or myocardial injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Database | Other | Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cardiovascular risk factors prevalence |
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Inclusion Criteria:
Exclusion Criteria:
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Patients admitted with a diagnosis of acute coronary syndrome or myocardial injury
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmine Pizzi, Prof | Contact | 0039 (0)512144933 | carmine.pizzi@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Carmine Pizzi, Dr | University of Bologna, Cardiology Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Sant'Orsola-Malpighi, Cardiology Department | Recruiting | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22199016 | Background | 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. | |
| 28739197 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D014947 | Wounds and Injuries |
| D000088442 | MINOCA |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003628 | Database Management Systems |
| ID | Term |
|---|---|
| D008331 | Management Information Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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Differences in percentage of patients with STEMI or NSTEMI, or type 1 or type 2 myocardial infarction with any risk factors
| 3 year |
| 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 |
| Differences in clinical presentation | Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias) | 3 year |
| Differences in clinical presentation | Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias) | 1 year |
| Differences in clinical presentation | Prevalence of patients presenting with ST elevation, angina, dyspnea, atypical chest pain, cardiogenic shock, arrhytmias) | 5 year |
| 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 |
| Differences in flow characteristics | TIMI, TIMI frame count | 1 year |
| Differences in flow characteristics | TIMI, TIMI frame count | 3 year |
| Differences in flow characteristics | TIMI, TIMI frame count | 5 year |
| Differences and impact of periprocedural ischemic complications | Type 4a myocardial infarction, periprocedural myocardial injury | 5 year |
| Ospedale Maggiore Carlo Alberto Pizzardi | Recruiting | Bologna | BO | 40133 | Italy |
|
| Ospedale Morgagni - Pierantoni | Recruiting | Forlì | FC | 47121 | Italy |
|
| Background |
| 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. |
| 25331532 | Background | 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. |
| 30571511 | Background | 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. |
| 37261384 | Derived | 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. |
| 34560876 | Derived | 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. |
| D009203 |
| Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |