Viewing Study NCT02438085



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Last Modification Date: 2024-10-26 @ 11:42 AM
Study NCT ID: NCT02438085
Status: RECRUITING
Last Update Posted: 2023-11-14
First Post: 2015-04-30

Brief Title: Prospective Registry of Acute Coronary Syndromes in Ferrara
Sponsor: University Hospital of Ferrara
Organization: University Hospital of Ferrara

Study Overview

Official Title: Acute coRonary sYndrOmes proSpective regisTry Of Ferrara
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ARYOSTO
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 400000 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None