Acute Coronary SyndromeNCT04255537
Clinical Governance of Patients With Acute Coronary Syndrome in Italy
An observational study of Acute Coronary Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 9 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 3,000 participants
- Where
- 9 sitesItaly
- Study dates
- 1 Jan 2018to May 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is designed to include a consecutive and all-comers population hospitalized with a diagnosis of ACS at admission.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Italy9 sites, 7 recruiting
- Recruiting
Azienda Usl di Bologna
Bologna, 40124
Casella Gianni, MD, gianni.casella@ausl.bologna.it
- Recruiting
Ferrara University Hospital
Cona, Ferrara
Gianluca Campo, MD, cmpglc@unife.it
- Withdrawn
ASST Cremona
Cremona, 26100
- Recruiting
Ospedale Morgagni-Pierantoni
Forlì, Forlì-Cesena, 47121
Ottani Filippo, MD, popilafittoni@gmail.com
- Recruiting
IRCCS Policlinico S. Matteo
Pavia, 27100
Sergio Leonardi, MD
- Active, not recruiting
Ospedale Santa Maria delle Croci
Ravenna, 48121
- Not yet recruiting
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Navazio Alessandro, MD, navazio.alessandro@ausl.re.it
- Recruiting
AUSL Romagna
Rimini, 47924
Grosseto Daniele, MD, dgrosseto@gmail.com
- Recruiting
IRCCS Multimedica
Sesto San Giovanni, Milano, 20099
De Servi Stefano, MD, stefano.deservi@multimedica.it
About this study
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.
Read the 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
- Keywords
- Myocardial Infarction, Quality Indicator, Percutaneous Coronary Intervention, Unstable Angina
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Time to reperfusion in patients with STEACS and optimal medical therapy at hospital discharge in patients with a final diagnosis of MI or UA.
Measured: 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.
Measured: Baseline
Examine associations of program participation with trends of QIs adherence over 1 year.
Measured: 1 year.
To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.
Measured: Baseline
To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.
Measured: 1 year.
To assess utilization of diagnostic imaging, laboratory tests and invasive procedures; and track hospital/coronary care unit length-of-stay data.
Measured: Baseline
Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.
Measured: Baseline
Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2018
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Ferrara, AUSL Romagna Rimini, Ospedale Morgagni-Pierantoni, IRCCS Multimedica, Azienda Usl di Bologna, Ospedale Santa Maria delle Croci, Azienda USL Reggio Emilia - IRCCS, ASST Cremona
- Responsible party
- Principal investigator, Sergio Leonardi, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Sergio Leonardi, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255537
- Sponsor's protocol ID
- ESR-16-12480
- Status last verified
- Feb 2020
- First submitted
- 15 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36124872Leonardi 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.
PubMed 33372102
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Governance of Patients With Acute Coronary Syndrome in Italy
- ClinicalTrials.gov ID
- NCT04255537
- Acronym / sponsor ID
- ESR-16-12480
- Conditions
- Acute Coronary Syndrome
- Keywords
- Myocardial Infarction, Quality Indicator, Percutaneous Coronary Intervention, Unstable Angina
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- University Hospital of Ferrara, AUSL Romagna Rimini, Ospedale Morgagni-Pierantoni, IRCCS Multimedica, Azienda Usl di Bologna, Ospedale Santa Maria delle Croci, Azienda USL Reggio Emilia - IRCCS, ASST Cremona
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is designed to include a consecutive and all-comers population hospitalized with a diagnosis of ACS at admission.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
Examine associations of program participation with trends of QIs adherence over 1 year.
Time frame: 1 year.
To monitor the characteristics, treatments, and outcomes of patients hospitalized with ACS.
Time frame: Baseline
To explore the association between evidence-based acute treatment strategies and risk-adjusted clinical outcomes.
Time frame: 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
Assess trends in medication dosing patterns, and improve drug safety through targeted quality feedback related to medication overdosing.
Time frame: Baseline
Identify barriers to implementing guideline recommendations for patients with AMI, and develop effective strategies to overcome these barriers
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 36124872Leonardi 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.
- Derived from this study: PubMed 33372102Leonardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Leonardi, MD principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 9 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Leonardi, MD (+39-0382-982105, s.leonardi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.