Clinical Governance of Patients With Acute Coronary Syndrome in Italy

NCT04255537 | Unknown

• 1 other identifier: ESR-16-12480
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

• 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 assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.

  Baseline

Study Arms (4)

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.

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.

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• University Hospital of Ferrara: collaborator
• AUSL Romagna Rimini: collaborator
• Ospedale Morgagni-Pierantoni: collaborator
• IRCCS Multimedica: collaborator
• Azienda Usl di Bologna: collaborator
• Ospedale Santa Maria delle Croci: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• ASST Cremona: collaborator

Study Sites (9)

Ferrara University Hospital

Cona, Ferrara, Italy

RECRUITING

Ospedale Morgagni-Pierantoni

Forlì, Forlì-Cesena, 47121, Italy

RECRUITING

IRCCS Multimedica

Sesto San Giovanni, Milano, 20099, Italy

RECRUITING

Azienda Usl di Bologna

Bologna, 40124, Italy

RECRUITING

ASST Cremona

Cremona, 26100, Italy

WITHDRAWN

IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, 48121, Italy

ACTIVE NOT RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, 42123, Italy

NOT YET RECRUITING

AUSL Romagna

Rimini, 47924, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 36124872 DERIVED

• 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.

  PMID: 33372102 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sergio Leonardi, MD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Leonardi, MD

CONTACT

+39-0382-982105; s.leonardi@smatteo.pv.it

Monica Portolan, M.Sc.

CONTACT

+39-0382-982105; m.portolan@smatteo.pv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 5, 2020
• Study Start: January 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

IT (9)