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Clinical Governance of Patients With Acute Coronary Syndrome in Italy

Clinical Governance of Patients With Acute Coronary Syndrome in Italy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04255537
Enrollment
3000
Registered
2020-02-05
Start date
2018-01-01
Completion date
2021-05-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Myocardial Infarction, Quality Indicator, Percutaneous Coronary Intervention, Unstable Angina

Brief summary

This is a prospective, observational, multicenter study that enroll consecutive and all-comers patients hospitalized with a diagnosis of Acute Coronary Syndrome (ACS) at admission.

Detailed description

This is a Quality Improvement Program which enroll all the consecutive patients hospitalized with ACS. The data elements that are central to the study include the primary and secondary quality indicators (QIs) that are used to define the performance and to promote improved quality of care. At least 3000 patients will be enrolled. The primary endpoint are assessed in-hospital, at admission and discharge. Patients will be followed for 1 year after the ACS.

Interventions

None listed

Sponsors

University Hospital of Ferrara
CollaboratorOTHER
AUSL Romagna Rimini
CollaboratorOTHER
Ospedale Morgagni-Pierantoni
CollaboratorUNKNOWN
IRCCS Multimedica
CollaboratorOTHER
Azienda Usl di Bologna
CollaboratorOTHER_GOV
Ospedale Santa Maria delle Croci
CollaboratorOTHER
Azienda USL Reggio Emilia - IRCCS
CollaboratorOTHER_GOV
ASST Cremona
CollaboratorUNKNOWN
Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* STEACS patients: symptoms of myocardial ischemia and persistent (i.e. \> 20 min) ST elevation in at least two contiguous ECG leads. N.B. Positive biomarkers of cardiac necrosis (i.e. troponin) are not required to confirm the diagnosis. New or presumably new left-bundle branch block at presentation occurs infrequently, may interfere with ST-elevation analysis, and should not be considered diagnostic of acute myocardial infarction (MI) in isolation. * NSTE-ACS patients: symptoms of myocardial ischemia of at least 10 minutes without persistent ST elevation in at least two contiguous ECG leads. To be included in this category patients should have at least one of the following two conditions: a) ECG evidence of NSTEACS defined as T wave inversion in leads with dominant R waves of at least of at least 1 mm (100 μV) or ST segment depression of at least 0.5 mm (50 μV) and/or b) Biomarker evidence of NSTEACS defined as at least one positive (i.e. above the 99th percentile upper reference limit) troponin value (i.e. NSTEMI) * A written informed consent (to agree for a contact, usually by telephone) is required only to patients who are discharged alive.

Exclusion criteria

* Subjects who, in the opinion of the investigator, are unable to comply with study follow up procedures, including, but not limited to, patients who are in prison, who are expected to move to a remote country, or who refuse to be followed should be excluded.

Design outcomes

Primary

MeasureTime frame
Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.Baseline

Secondary

MeasureTime frame
Examine associations of program participation with trends of QIs adherence over 1 year.1 year.
To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.Baseline
To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.1 year.
To measure adherence to a wide range of QIs within multiple domains of care including optimal ACS diagnosis, therapy, and individualized risk assessment through monitoring of process of care measures and benchmarked quality-of-care feedback reports.Baseline
Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.Baseline
Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriersBaseline
To assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.Baseline

Countries

Italy

Contacts

Primary ContactSergio Leonardi, MD
s.leonardi@smatteo.pv.it+39-0382-982105
Backup ContactMonica Portolan, M.Sc.
m.portolan@smatteo.pv.it+39-0382-982105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026