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Acute Cardiovascular DiseaseNCT06162247

Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)

An observational study of Acute Cardiovascular Disease and Acute Coronary Syndrome, run by Federico II University at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU. Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,000 participants
Where
1 siteItaly
Study dates
20 Nov 2023to 20 Nov 2033
Phase
Observational
Are there results?
Not yet: the study is under way

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: All adult patients with acute cardiovascular diseases admitted at our ICCU will be eligible for inclusion in the study, and only those not providing consent to data collection will be excluded.

Who may be able to join

  • Acute cardiovascular disease admitted at our ICCU
  • Age ≥18 years;
  • Written informed consent.

Who cannot join

  • 1) Patients not providing consent to data collection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Giuseppe Gargiulo, MD, PhD contact

+39-7462253

giuseppe.gargiulo1@unina.it

Giovanni Esposito, MD, PhD contact

+39-7463075

espogiov@unina.it

Italy1 site, 1 recruiting

  • Department of Advanced Biomedical Sciences, University Federico II of Naples

    Naples, 80131

    Giuseppe Gargiulo, MD, PhD, giuseppe.gargiulo1@unina.it

    Recruiting

Other trials in Italy

About this study

This protocol proposes to prospectively evaluate current epidemiology, pharmacologic and invasive management and clinical outcomes of patients with acute cardiovascular diseases admitted at our ICCU.

Read the detailed description

This study is designed as a single-center, investigator-initiated prospective observational study. Our ICCU is located at the Department of "Scienze Cardiovascolari, Diagnostica per Immagini, e Rete Tempo Dipendente delle Emergenze Cardiovascolari" of the Azienda Ospedaliera Universitaria Federico II. All scientific activities are performed in the Department of Advanced Biomedical Sciences of the University of Naples Federico II.

This is a prospective observational study which does not include pharmacologic or invasive treatments different from daily and guideline-directed management, but only collects data of patients for research purposes, therefore no specific treatments or procedures are included in this research protocol.

The Clinical Trial Unit at the University of Naples "Federico II" will oversee all study procedures and data management. The study data will be anonymized and managed using REDCap electronic data capture, which is hosted at the University of Naples "Federico II".

Once the patient is admitted to our ICCU, the informed consent will be signed and all data will be collected: demographic, clinical, procedural, therapeutic, and outcome data.

Clinical outcomes will be assessed in the in-hospital period, at 30 days, at 1-year and at the longest available follow-up (telephone or follow-up visit).

Main clinical outcomes will be adjudicated by an independent clinical events committee (CEC).

Medical subject headings
Acute Coronary Syndrome, Shock, Cardiogenic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Number of patients with all-cause mortality

    Measured: 30 days, 1 year

  2. Cardiovascular mortality

    Number of patients with cardiovascular mortality

    Measured: 30 days, 1 year

  3. Myocardial infarction

    Number of patients with myocardial infarction

    Measured: 30 days, 1 year

  4. Stent thrombosis

    Number of patients with stent thrombosis

    Measured: 30 days, 1 year

  5. Stroke

    Number of patients with stroke

    Measured: 30 days, 1 year

  6. Heart Failure

    Number of patients with heart failure

    Measured: 30 days, 1 year

  7. Hospitalization for heart failure

    Number of patients with hospitalization for heart failure

    Measured: 30 days, 1 year

  8. Bleeding

    Number of patients with bleeding

    Measured: 30 days, 1 year

  9. Acute kidney injury

    Number of patients with acute kidney injury

    Measured: 30 days, 1 year

  10. Target vessel revascularization

    Number of patients with target vessel revascularization

    Measured: 30 days, 1 year

  11. Target lesion revascularization

    Number of patients with target lesion revascularization

    Measured: 30 days, 1 year

  12. Hospital length of stay

    Duration of hospitalization in days

    Measured: 0 to 30 days (or more depending on diration of hospitalization)

  13. Metrics of diuretic response and decongestion

    Diuresis quantification, weight loss, decongestion score, etc.

    Measured: 0 to 30 days (or more depending on diration of hospitalization)

  14. Poor neurologic outcomes

    Number of patients with poor neurologic outcomes

    Measured: 30 days, 1 year

  15. ICCU length of stay

    Duration of ICCU hospitalization in days

    Measured: 0 to 30 days (or more depending on diration of hospitalization)

  16. Metrics of need for mechanical circulatory support and vasopressors/inotropes

    Need for MCS, MCS type and duration; need for vasopressors/inotropes, vasopressors/inotropes types and duration

    Measured: 0 to 30 days (or more depending on diration of hospitalization)

  17. Quality of life

    Quality of life assessment by various scores or questionnaires

    Measured: 30 days, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start20 Nov 2023
  3. Primary completion20 Nov 2033 (estimated)
  4. Study completion20 Nov 2033 (estimated)

Resources

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
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162247
Sponsor's protocol ID
Naples FED2-ICCU Registry
Other IDs
CET Campania 3 86/2023
Status last verified
Feb 2025
First submitted
18 Nov 2023
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.

    PubMed 37622654

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

    PubMed 37622666

  • 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 36124872

  • Nadarajah R, Ludman P, Appelman Y, Brugaletta S, Budaj A, Bueno H, Huber K, Kunadian V, Leonardi S, Lettino M, Milasinovic D, Gale CP; NSTEMI Investigators. Cohort profile: the ESC EURObservational Research Programme Non-ST-segment elevation myocardial infraction (NSTEMI) Registry. Eur Heart J Qual Care Clin Outcomes. 2022 Dec 13;9(1):8-15. doi: 10.1093/ehjqcco/qcac067.

    PubMed 36259751

  • De Filippo O, D'Ascenzo F, Wanha W, Leonardi S, Raposeiras Roubin S, Fabris E, Truffa Giachet A, Huczek Z, Gaibazzi N, Ielasi A, Cortese B, Borin A, Nunez-Gil IJ, Ugo F, Marengo G, Bianco M, Barbieri L, Marchini F, Desperak P, Melendo-Viu M, Montalto C, Bruno F, Mancone M, Ferrandez-Escarabajal M, Morici N, Scaglione M, Tuttolomondo D, Gasior M, Mazurek M, Gallone G, Campo G, Wojakowski W, Abu Assi E, Sinagra G, de Ferrari GM. IncidenCe and predictOrs of heaRt fAiLure after acute coronarY Syndrome: The CORALYS registry. Int J Cardiol. 2023 Jan 1;370:35-42. doi: 10.1016/j.ijcard.2022.10.146. Epub 2022 Oct 25.

    PubMed 36306949

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Cardiovascular Disease and Acute Coronary Syndrome, run by Federico II University at 1 site 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: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giuseppe Gargiulo, MD, PhD (+39-7462253, giuseppe.gargiulo1@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 30 days, 1 year). The study lists 17 primary outcomes in all. 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 NCT06162247, which also lists 5 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 3 Mar 2025.

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