Prospective Registry of Acute Coronary Syndromes in Ferrara
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prospective collection of data and follow-up.
- Who it may be relevant to
- Registry conditions: Acute Coronary Syndromes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acute coRonary sYndrOmes proSpective regisTry Of Ferrara
Overview
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
- Other prospective collection of data and follow-up
prospective collection of data and follow-up of all patients admitted to hospital for ACS
Primary outcome measures
- 1-year combined primary endpoint [Time frame: 1 year]
Secondary outcome measures (7)
- 2-year combined endpoint [Time frame: 2 years]
- 3-year combined endpoint [Time frame: 3 years]
- 5-year combined endpoint [Time frame: 5 years]
- annual occurrence of single components of primary endpoint [Time frame: 1, 2, 3, 4, 5 years]
- primary safety outcome [Time frame: 1 year]
- cardiac adverse events [Time frame: 1, 2, 3, 4, 5 years]
- respiratory adverse events [Time frame: 1, 2, 3, 4, 5 years]
Eligibility criteria
Inclusion criteria
- age >18 years
- hospital admission for acute coronary syndromes
- resident in the Ferrara area
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University Hospital of Ferrara — Cona
Publications
- 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. PMID 35915019
- 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. PMID 35160005
Identifiers
NCT: NCT02438085 · 073132