Clinical Governance of Patients With Acute Coronary Syndrome in Italy

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04255537
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-01-15
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.	Baseline
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
Examine associations of program participation with trends of QIs adherence over 1 year.	1 year.
Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriers	Baseline
To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.	1 year.
To assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.	Baseline
Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.	Baseline

Trial Locations

Locations (9)

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Forlì-Cesena, Italy

Ferrara University Hospital; 🇮🇹 Cona, Ferrara, Italy

Arcispedale Santa Maria Nuova; 🇮🇹 Reggio Emilia, Italy

Ospedale Santa Maria delle Croci; 🇮🇹 Ravenna, Italy

AUSL Romagna; 🇮🇹 Rimini, Italy

IRCCS Multimedica; 🇮🇹 Sesto San Giovanni, Milano, Italy

IRCCS Policlinico S. Matteo; 🇮🇹 Pavia, Italy

ASST Cremona; 🇮🇹 Cremona, Italy

Azienda Usl di Bologna; 🇮🇹 Bologna, Italy