Prospective Registry of Acute Coronary Syndromes in Ferrara — ARYOSTO  

Acute Coronary Syndromes Clinical Trial

Official title: Acute coRonary sYndrOmes proSpective regisTry Of Ferrara

Status Recruiting

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)

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

• NCT number: NCT02438085
• Study type: Observational [Patient Registry]
• Source: University Hospital of Ferrara
• Contact: Veronica Lodolini, BSc
• Phone: +390532236450
• Email: veronica.lodolini@student.unife.it
• Status: Recruiting
• Start date: June 2014
• Completion date: November 30, 2032