Clinical Governance of Patients With Acute Coronary Syndrome in Italy

Acute Coronary Syndrome Clinical Trial

Official title:

Clinical Governance of Patients With Acute Coronary Syndrome in Italy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255537
• Other study ID #: ESR-16-12480
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: May 2021

Study information

• Verified date: February 2020
• Source: Foundation IRCCS San Matteo Hospital
• Contact: Sergio Leonardi, MD
• Phone: +39-0382-982105
• Email: s.leonardi[@]smatteo.pv.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Italy	Azienda Usl di Bologna	Bologna
Italy	Ferrara University Hospital	Cona	Ferrara
Italy	ASST Cremona	Cremona
Italy	Ospedale Morgagni-Pierantoni	Forlì	Forlì-Cesena
Italy	IRCCS Policlinico S. Matteo	Pavia
Italy	Ospedale Santa Maria delle Croci	Ravenna
Italy	Arcispedale Santa Maria Nuova	Reggio Emilia
Italy	AUSL Romagna	Rimini
Italy	IRCCS Multimedica	Sesto San Giovanni	Milano

Sponsors (9)

Lead Sponsor	Collaborator
Foundation IRCCS San Matteo Hospital	Arcispedale Santa Maria Nuova-IRCCS, ASST Cremona, AUSL Romagna Rimini, Azienda Usl di Bologna, IRCCS Multimedica, Ospedale Morgagni-Pierantoni, Ospedale Santa Maria delle Croci, University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

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