Acute Coronary SyndromesARYOSTONCT02438085
Prospective Registry of Acute Coronary Syndromes in Ferrara
An observational study of Acute Coronary Syndromes, run by University Hospital of Ferrara at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- What is being tested?
- prospective collection of data and follow-up
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to 30 Nov 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to hospital with diagnosis of acute coronary syndromes according current European guidelines
Who may be able to join
- age >18 years
- hospital admission for acute coronary syndromes
- resident in the Ferrara area
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Ferrara
Cona, Ferrara, 44124
Veronica Lodolini, +390532236450, ldlvnc@unife.it
Gianluca Campo, MD
About this study
Official title: 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)
Read the 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
- Being tested
- prospective collection of data and follow-up
- Keywords
- acute coronary syndromes, outcome, medical management, comorbidities, registry
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective collection of data and follow-upOther
prospective collection of data and follow-up of all patients admitted to hospital for ACS
| Study group | Role | What they receive |
|---|---|---|
| ACS patients | prospective collection of data and follow-up Receives: Other: prospective collection of data and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year combined primary endpoint
1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
Measured: 1 year
Secondary outcomes (7)
2-year combined endpoint
2-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
Measured: 2 years
3-year combined endpoint
3-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
Measured: 3 years
5-year combined endpoint
5-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
Measured: 5 years
annual occurrence of single components of primary endpoint
occurrence of each component of the primary endpoint
Measured: 1, 2, 3, 4, 5 years
primary safety outcome
1 year occurrence of BARC 2-3 bleedings
Measured: 1 year
cardiac adverse events
hospital admission heart failure, arrhytmias, acute coronary syndromes, admission to emergency room for chest pain
Measured: 1, 2, 3, 4, 5 years
respiratory adverse events
hospital admission for respiratory cause
Measured: 1, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJun 2014
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438085
- Sponsor's protocol ID
- 073132
- Acronym
- ARYOSTO
- Status last verified
- Nov 2023
- First submitted
- 30 Apr 2015
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vitali F, Azzolini G, Zuin M, Bianchi N, Malagu M, De Raffele M, Cantone A, Sanguettoli F, Gibiino F, Balla C, Tonet E, Pavasini R, Campo G, Bertini M. Sex differences in electrocardiographic patterns among patients with acute coronary syndromes. Front Cardiovasc Med. 2026 Oct 12;13:1758485. doi: 10.3389/fcvm.2026.1758485. eCollection 2026.
PubMed 42935992Cimaglia 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.
PubMed 35915019Pavasini 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.
PubMed 35160005
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute coRonary sYndrOmes proSpective regisTry Of Ferrara
- ClinicalTrials.gov ID
- NCT02438085
- Acronym / sponsor ID
- ARYOSTO / 073132
- Conditions
- Acute Coronary Syndromes
- Keywords
- acute coronary syndromes, outcome, medical management, comorbidities, registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS patients | – | Other: prospective collection of data and follow-upprospective collection of data and follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to hospital with diagnosis of acute coronary syndromes according current European guidelines
Key inclusion criteria (3 listed)
- age >18 years
- hospital admission for acute coronary syndromes
- resident in the Ferrara area
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective collection of data and follow-upprospective collection of data and follow-up of all patients admitted to hospital for ACS | Other | ACS patients |
Primary outcome
1-year combined primary endpoint
Time frame: 1 year
1-year occurence of cardiac death, myocardial infarction, cerebrovascular accident
7 secondary outcomes
2-year combined endpoint
Time frame: 2 years
3-year combined endpoint
Time frame: 3 years
5-year combined endpoint
Time frame: 5 years
annual occurrence of single components of primary endpoint
Time frame: 1, 2, 3, 4, 5 years
primary safety outcome
Time frame: 1 year
cardiac adverse events
Time frame: 1, 2, 3, 4, 5 years
respiratory adverse events
Time frame: 1, 2, 3, 4, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 42935992Vitali F, Azzolini G, Zuin M, Bianchi N, Malagu M, De Raffele M, Cantone A, Sanguettoli F, Gibiino F, Balla C, Tonet E, Pavasini R, Campo G, Bertini M. Sex differences in electrocardiographic patterns among patients with acute coronary syndromes. Front Cardiovasc Med. 2026 Oct 12;13:1758485. doi: 10.3389/fcvm.2026.1758485. eCollection 2026.
- Derived from this study: PubMed 35915019Cimaglia 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.
- Derived from this study: PubMed 35160005Pavasini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Lodolini, BSc (+390532236450, veronica.lodolini@student.unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year combined primary endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438085, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.