Prospective Registry of Acute Coronary Syndromes in Ferrara

Acute Coronary Syndromes Clinical Trial

— ARYOSTO  

Official title:

Acute coRonary sYndrOmes proSpective regisTry Of Ferrara

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02438085
• Other study ID #: 073132
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Syndrome

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