Clinical Governance of Patients With Acute Coronary Syndrome in Italy

February 2, 2020 updated by: Sergio Leonardi, Foundation IRCCS San Matteo Hospital
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40124
      • Cremona, Italy, 26100
        • Withdrawn
        • ASST Cremona
      • Pavia, Italy, 27100
        • Recruiting
        • IRCCS Policlinico S. Matteo
        • Principal Investigator:
          • Sergio Leonardi, MD
      • Ravenna, Italy, 48121
        • Active, not recruiting
        • Ospedale Santa Maria delle Croci
      • Reggio Emilia, Italy, 42123
      • Rimini, Italy, 47924
    • Ferrara
      • Cona, Ferrara, Italy
        • Recruiting
        • Ferrara University Hospital
        • Contact:
    • Forlì-Cesena
      • Forlì, Forlì-Cesena, Italy, 47121
    • Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation IRCCS San Matteo Hospital

Collaborators

Azienda Usl di Bologna
University Hospital of Ferrara
Arcispedale Santa Maria Nuova-IRCCS
IRCCS Multimedica
AUSL Romagna Rimini
Ospedale Santa Maria delle Croci
Ospedale Morgagni-Pierantoni
ASST Cremona

Investigators

  • Principal Investigator: Sergio Leonardi, MD, IRCCS Policlinico S. Matteo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-16-12480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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