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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02438085
Other study ID # 073132
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2014
Est. completion date November 30, 2032

Study information

Verified date November 2023
Source University Hospital of Ferrara
Contact Veronica Lodolini, BSc
Phone +390532236450
Email veronica.lodolini@student.unife.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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)


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


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date November 30, 2032
Est. primary completion date November 30, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 years - hospital admission for acute coronary syndromes - resident in the Ferrara area Exclusion Criteria: - none

Study Design


Intervention

Other:
prospective collection of data and follow-up
prospective collection of data and follow-up of all patients admitted to hospital for ACS

Locations

Country Name City State
Italy University Hospital of Ferrara Cona Ferrara

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other emergency room admittance assessment of number of admission to emergency room for any causes 1, 2, 3, 4, 5 years
Primary 1-year combined primary endpoint 1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident 1 year
Secondary 2-year combined endpoint 2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident 2 years
Secondary 3-year combined endpoint 3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident 3 years
Secondary 5-year combined endpoint 5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident 5 years
Secondary annual occurrence of single components of primary endpoint occurrence of each component of the primary endpoint 1, 2, 3, 4, 5 years
Secondary primary safety outcome 1 year occurrence of BARC 2-3 bleedings 1 year
Secondary cardiac adverse events hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain 1, 2, 3, 4, 5 years
Secondary respiratory adverse events hospital admission for respiratory cause 1, 2, 3, 4, 5 years
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