Clinical Governance of Patients With Acute Coronary Syndrome in Italy

NCT ID: NCT04255537

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-05-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with STEACS intended for urgent angio/reperfusion.

This population mostly includes STEACS patients for whom primary PCI is intended. A minority of this population includes patients with STEACS intended for urgent angiography for persistent ST elevation and/or symptoms but with symptoms onset \> 12 hours (secondary PCI), urgent angiography after failed fibrinolysis (rescue PCI), or patients receiving fibrinolysis.

No interventions assigned to this group

Patients with STEACS NOT intended for urgent angio/reperfusion

This population mostly includes STEACS patients not receiving reperfusion for late presentation (i.e. \> 12 hours) or patient preference. Note that patient in this category may receive diagnostic angiography for better diagnostic assessment and/or risk stratification but NOT on an urgent basis.

No interventions assigned to this group

Patients with NSTEACS intended for invasive management

This population includes patients with NSTEACS managed invasively with coronary angiography within 72 hours. Most patients are a high-risk feature (i.e. positive troponin, GRACE risk score \> 140, hemodynamic/electrical instability) for whom angiography is intended.

No interventions assigned to this group

Patients with NSTEACS NOT intended for invasive management

This population includes patients who are candidate for an initially conservative strategy. Note that this category may include patients who are subsequently managed with coronary angiography, including recurring symptoms of myocardial ischemia, or hemodynamic/ electrical instability.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: collaborator

AUSL Romagna Rimini

OTHER

Sponsor Role: collaborator

Ospedale Morgagni-Pierantoni

UNKNOWN

Sponsor Role: collaborator

IRCCS Multimedica

OTHER

Sponsor Role: collaborator

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role: collaborator

Ospedale Santa Maria delle Croci

OTHER

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

ASST Cremona

UNKNOWN

Sponsor Role: collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Sergio Leonardi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergio Leonardi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

Ferrara University Hospital

Cona, Ferrara, Italy

Site Status: RECRUITING

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, Italy

Site Status: RECRUITING

IRCCS Multimedica

Sesto San Giovanni, Milano, Italy

Site Status: RECRUITING

Azienda Usl di Bologna

Bologna, , Italy

Site Status: RECRUITING

ASST Cremona

Cremona, , Italy

Site Status: WITHDRAWN

IRCCS Policlinico S. Matteo

Pavia, , Italy

Site Status: RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, , Italy

Site Status: ACTIVE_NOT_RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, , Italy

Site Status: NOT_YET_RECRUITING

AUSL Romagna

Rimini, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Sergio Leonardi, MD

Role: CONTACT

s.leonardi@smatteo.pv.it

+39-0382-982105

Monica Portolan, M.Sc.

Role: CONTACT

m.portolan@smatteo.pv.it

+39-0382-982105

Facility Contacts

Gianluca Campo, MD

Role: primary

cmpglc@unife.it

Ottani Filippo, MD

Role: primary

popilafittoni@gmail.com

De Servi Stefano, MD

Role: primary

stefano.deservi@multimedica.it

Casella Gianni, MD

Role: primary

gianni.casella@ausl.bologna.it

Navazio Alessandro, MD

Role: primary

navazio.alessandro@ausl.re.it

Grosseto Daniele, MD

Role: primary

dgrosseto@gmail.com

References

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.

Reference Type: DERIVED

PMID: 36124872 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33372102 (View on PubMed)

Other Identifiers

ESR-16-12480

Identifier Type: -

Identifier Source: org_study_id