Acute Coronary Syndromes
Conditions
Keywords
acute coronary syndromes, outcome, medical management, comorbidities, registry
Brief summary
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
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
Interventions
OTHERprospective collection of data and follow-up
prospective collection of data and follow-up of all patients admitted to hospital for ACS
Sponsors
University Hospital of Ferrara
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years * hospital admission for acute coronary syndromes * resident in the Ferrara area
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year combined primary endpoint | 1 year | 1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year combined endpoint | 2 years | 2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident |
| 3-year combined endpoint | 3 years | 3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident |
| 5-year combined endpoint | 5 years | 5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident |
| primary safety outcome | 1 year | 1 year occurrence of BARC 2-3 bleedings |
| cardiac adverse events | 1, 2, 3, 4, 5 years | hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain |
| respiratory adverse events | 1, 2, 3, 4, 5 years | hospital admission for respiratory cause |
| annual occurrence of single components of primary endpoint | 1, 2, 3, 4, 5 years | occurrence of each component of the primary endpoint |
Other
| Measure | Time frame | Description |
|---|---|---|
| emergency room admittance | 1, 2, 3, 4, 5 years | assessment of number of admission to emergency room for any causes |
Countries
Italy
Contacts
Primary ContactVeronica Lodolini, BSc
Outcome results
None listed