Prospective Registry of Acute Coronary Syndromes in Ferrara (ARYOSTO)

Acute coRonary sYndrOmes proSpective regisTry Of Ferrara

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)

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Other: prospective collection of data and follow-up

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

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Veronica Lodolini, BSc; Phone Number: +390532236450; Email: veronica.lodolini@student.unife.it

Study Locations

• Italy
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Recruiting
      • University Hospital of Ferrara
      • Sub-Investigator: Andrea Erriquez, MD
      • Sub-Investigator: Carlo Penzo, MD
      • Contact: Veronica Lodolini; Phone Number: +390532236450; Email: ldlvnc@unife.it
      • Principal Investigator: Gianluca Campo, MD
      • Sub-Investigator: Simone Biscaglia, MD
      • Sub-Investigator: Carlo Tumscitz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to hospital with diagnosis of acute coronary syndromes according current European guidelines

Description

Inclusion Criteria:

• age >18 years
• hospital admission for acute coronary syndromes
• resident in the Ferrara area

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACS patients; prospective collection of data and follow-up	Other: prospective collection of data and follow-up; prospective collection of data and follow-up of all patients admitted to hospital for ACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year combined primary endpoint	1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year combined endpoint	2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident	2 years
3-year combined endpoint	3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident	3 years
5-year combined endpoint	5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident	5 years
annual occurrence of single components of primary endpoint	occurrence of each component of the primary endpoint	1, 2, 3, 4, 5 years
primary safety outcome	1 year occurrence of BARC 2-3 bleedings	1 year
cardiac adverse events	hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain	1, 2, 3, 4, 5 years
respiratory adverse events	hospital admission for respiratory cause	1, 2, 3, 4, 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
emergency room admittance	assessment of number of admission to emergency room for any causes	1, 2, 3, 4, 5 years

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2032

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 5, 2015
• First Posted (Estimated): May 8, 2015

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: comorbidities; outcome; registry; medical management; acute coronary syndromes
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 073132