Clinical trial NCT04255537: Clinical Governance of Patients With Acute Coronary Syndrome in Italy
Official title: Clinical Governance of Patients With Acute Coronary Syndrome in Italy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Keywords: Myocardial Infarction
Quality Indicator
Percutaneous Coronary Intervention
Unstable Angina
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: University Hospital of Ferrara
name: AUSL Romagna Rimini
name: Ospedale Morgagni-Pierantoni
name: IRCCS Multimedica
name: Azienda Usl di Bologna
name: Ospedale Santa Maria delle Croci
name: Azienda USL Reggio Emilia - IRCCS
name: ASST Cremona
First posted: 2020-02-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is designed to include a consecutive and all-comers population hospitalized with a diagnosis of ACS at admission.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: Examine associations of program participation with trends of QIs adherence over 1 year.
timeFrame: 1 year.
measure: To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.
timeFrame: Baseline
measure: To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.
timeFrame: 1 year.
measure: To assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.
timeFrame: Baseline
measure: Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.
timeFrame: Baseline
measure: Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriers
timeFrame: Baseline
Other outcomes:
Locations:
city: Cona
country: Italy
facility: Ferrara University Hospital
state: Ferrara
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
state: Forlì-Cesena
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
state: Milano
city: Bologna
country: Italy
facility: Azienda Usl di Bologna
city: Cremona
country: Italy
facility: ASST Cremona
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: AUSL Romagna
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Sergio Leonardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leonardi S, Montalto C, Carrara G, Casella G, Grosseto D, Galazzi M, Repetto A, Tua L, Portolan M, Ottani F, Galvani M, Gentile L, Cardelli LS, De Servi S, Antonelli A, De Ferrari GM, Visconti LO, Campo G; ACS Clinical Governance Programme Investigators. Clinical governance of patients with acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2022 Nov 30;11(11):797-805. doi: 10.1093/ehjacc/zuac106.
citation: Leonardi S, Montalto C, Casella G, Grosseto D, Repetto A, Portolan M, Fortuni F, Ottani F, Galvani M, Cardelli LS, De Servi S, Rubboli A, De Ferrari GM, Oltrona Visconti L, Campo G. Clinical governance programme in patients with acute coronary syndrome: design and methodology of a quality improvement initiative. Open Heart. 2020 Dec;7(2):e001415. doi: 10.1136/openhrt-2020-001415.