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The ARYOSTO has been designed to describe the clinical epidemiology and the current management of acute coronary syndromes (ACS) in the area of Ferrara. Especially, the Authors will evaluate the medical and interventional management of ACS patients admitted to hospitals in the area of Ferrara and receiving coronary artery angiography and percutaneous coronary intervention (PCI) in the hub center of Ferrara (Azienda Ospedaliera Universitaria di Ferrara, Cona (FE), Italy)
The Cardiovascular Institute of the University Hospital of Ferrara is the hub center of the area of Ferrara (400.000 residents). The cath-lab of the University Hospital of Ferrara is the hub center of the network for the management of patients with ACS. This finding guarantees a very high number of patients with ACS admitted to University Hospital of Ferrara (more than 1500 by year). In the cath-lab are performed more than 2000 coronary artery angiography by year and more than 1100 PCI by year. The staff of the cardiology unit has a great experience in the management of studies (investigator-driven, randomized controlled trials, with or without sponsor) enrolling patients with ACS and treated with PCI. All consecutive patients with ACS admitted to hospitals of the Ferrara area will be included in the registry. All data will be related to long-term clinical outcome.
METHODS:
Prospective collection of following data:
PRE-SPECIFIED SUBSTUDY
The Authors will focus the attention in specific subset of patients:
Similarly, a specifc substudy of the registry will be focused on the characterization of coronary artery disease and of atherosclerotic plaque morphology in patients with comorbidities (diabetes, COPD, CKD, malignancy) as compared to patients without comorbidities.
Finally, the Authors will evaluate the quality of life of ACS patients in the area of Ferrara applying at 1, 2, 3, 4 and 5 years the following questionnaires: EQ-5D and SF-12 v2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACS patients | prospective collection of data and follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prospective collection of data and follow-up | Other | prospective collection of data and follow-up of all patients admitted to hospital for ACS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year combined primary endpoint | 1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year combined endpoint | 2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident | 2 years |
| 3-year combined endpoint | 3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident |
| Measure | Description | Time Frame |
|---|---|---|
| emergency room admittance | assessment of number of admission to emergency room for any causes | 1, 2, 3, 4, 5 years |
Inclusion Criteria:
Exclusion Criteria:
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patients admitted to hospital with diagnosis of acute coronary syndromes according current European guidelines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronica Lodolini, BSc | Contact | +390532236450 | veronica.lodolini@student.unife.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Ferrara | Recruiting | Cona | Ferrara | 44124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35915019 | Derived | Cimaglia P, Fortini F, Vieceli Dalla Sega F, Cardelli LS, Massafra RF, Morelli C, Trichilo M, Ferrari R, Rizzo P, Campo G. Relationship between PCSK9 and endothelial function in patients with acute myocardial infarction. Nutr Metab Cardiovasc Dis. 2022 Sep;32(9):2105-2111. doi: 10.1016/j.numecd.2022.06.020. Epub 2022 Jul 2. | |
| 35160005 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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whole blood, plasma, serum
| 3 years |
| 5-year combined endpoint | 5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident | 5 years |
| annual occurrence of single components of primary endpoint | occurrence of each component of the primary endpoint | 1, 2, 3, 4, 5 years |
| primary safety outcome | 1 year occurrence of BARC 2-3 bleedings | 1 year |
| cardiac adverse events | hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain | 1, 2, 3, 4, 5 years |
| respiratory adverse events | hospital admission for respiratory cause | 1, 2, 3, 4, 5 years |
| Pavasini R, Fabbri G, Marchini F, Bianchi N, Deserio MA, Sanguettoli F, Verardi FM, Segala D, Pompei G, Tonet E, Serenelli M, Caglioni S, Guardigli G, Campo G, Cultrera R. Procalcitonin Predicts Bacterial Infection, but Not Long-Term Occurrence of Adverse Events in Patients with Acute Coronary Syndrome. J Clin Med. 2022 Jan 22;11(3):554. doi: 10.3390/jcm11030554. |