Prospective Registry of Acute Coronary Syndromes in Ferrara

NCT ID: NCT02438085

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2032-11-30

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 (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

Conditions

Acute Coronary Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ACS patients

prospective collection of data and follow-up

prospective collection of data and follow-up

Intervention Type: OTHER

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

Interventions

prospective collection of data and follow-up

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

Assistant Professor and Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Ferrara

Cona, Ferrara, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Veronica Lodolini, BSc

Role: CONTACT

veronica.lodolini@student.unife.it

+390532236450

Facility Contacts

Veronica Lodolini

Role: primary

ldlvnc@unife.it

+390532236450

References

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.

Reference Type: DERIVED

PMID: 35915019 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35160005 (View on PubMed)

Other Identifiers

073132

Identifier Type: -

Identifier Source: org_study_id