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NCT Number: NCT02438085

Prospective Registry of Acute Coronary Syndromes in 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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location status: Recruiting

Location contact

Andrea Erriquez, MD

SUB_INVESTIGATOR

Carlo Penzo, MD

SUB_INVESTIGATOR

Carlo Tumscitz, MD

SUB_INVESTIGATOR

Gianluca Campo, MD

PRINCIPAL_INVESTIGATOR

Simone Biscaglia, MD

SUB_INVESTIGATOR

Veronica Lodolini

CONTACT

[email protected]

+390532236450

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

prospective collection of data and follow-up

Other

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

Primary outcomes

  1. 1-year combined primary endpoint

    Time frame: 1 year

    1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident

Secondary outcomes

  1. 2-year combined endpoint

    Time frame: 2 years

    2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident

  2. 3-year combined endpoint

    Time frame: 3 years

    3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident

  3. 5-year combined endpoint

    Time frame: 5 years

    5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident

  4. annual occurrence of single components of primary endpoint

    Time frame: 1, 2, 3, 4, 5 years

    occurrence of each component of the primary endpoint

  5. primary safety outcome

    Time frame: 1 year

    1 year occurrence of BARC 2-3 bleedings

  6. cardiac adverse events

    Time frame: 1, 2, 3, 4, 5 years

    hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain

  7. respiratory adverse events

    Time frame: 1, 2, 3, 4, 5 years

    hospital admission for respiratory cause

Other outcomes

  1. emergency room admittance

    Time frame: 1, 2, 3, 4, 5 years

    assessment of number of admission to emergency room for any causes

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica Lodolini, BSc

CONTACT

[email protected]

+390532236450

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Acute coRonary sYndrOmes proSpective regisTry Of Ferrara

Acronym: ARYOSTO

Important dates

Study start
2014
Primary completion
2028
Study completion
2032
First posted
May 8, 2015
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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