NCT02438085

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
79mo left

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2014Nov 2032

Study Start

First participant enrolled

June 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
13.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2032

Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

14.5 years

First QC Date

April 30, 2015

Last Update Submit

November 12, 2023

Conditions

Keywords

acute coronary syndromesoutcomemedical managementcomorbiditiesregistry

Outcome Measures

Primary Outcomes (1)

  • 1-year combined primary endpoint

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

    1 year

Secondary Outcomes (7)

  • 2-year combined endpoint

    2 years

  • 3-year combined endpoint

    3 years

  • 5-year combined endpoint

    5 years

  • annual occurrence of single components of primary endpoint

    1, 2, 3, 4, 5 years

  • primary safety outcome

    1 year

  • +2 more secondary outcomes

Other Outcomes (1)

  • emergency room admittance

    1, 2, 3, 4, 5 years

Study Arms (1)

ACS patients

prospective collection of data and follow-up

Other: prospective collection of data and follow-up

Interventions

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

ACS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

RECRUITING

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, plasma, serum

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Interventional Cardiologist

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 8, 2015

Study Start

June 1, 2014

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2032

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations