Prospective Registry of Acute Coronary Syndromes in Ferrara

Study Overview
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Brief Summary
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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)

Detailed Description
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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: baseline characteristics including cardiovascular (CV) risk factors, CV history and comorbidities (see below) clinical management (CV drugs, imaging exams, diagnostic exams, time to cath-lab access) biomarkers evaluating inflammation, endothelial, platelet, thrombotic function and activation procedural details including coronary disease description, intervention modality, stent, coronary imaging, CV drugs during intervention, procedural complications and management, access site in-hospital adverse events medical treatment at discharge and during the follow-up clinical follow-up (1, 2, 3, 4 5 years) PRE-SPECIFIED SUBSTUDY The Authors will focus the attention in specific subset of patients: patients with diabetes patients with chronic obstructive pulmonary disease patients with chronic kidney disease patients with rheumatologic disordes patients with malignancy In these subsets of patients the Authors will collect a more detailed description of symptoms, clinical presentation, disease management and relationship between comorbidity and ACS. 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

Official Title
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Acute coRonary sYndrOmes proSpective regisTry Of Ferrara

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Other: prospective collection of data and follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years hospital admission for acute coronary syndromes resident in the Ferrara area Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACS patients<br>prospective collection of data and follow-up | Other: prospective collection of data and follow-up<br>* prospective collection of data and follow-up of all patients admitted to hospital for ACS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year combined primary endpoint | 1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndromes, outcome, medical management, comorbidities, registry