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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Cardiogenic Shock; Acute Heart Failure; Acute Cardiovascular Disease

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).

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Giuseppe Gargiulo, MD, PhD; Phone Number: +39-7462253; Email: giuseppe.gargiulo1@unina.it
• Study Contact Backup: Name: Giovanni Esposito, MD, PhD; Phone Number: +39-7463075; Email: espogiov@unina.it

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Department of Advanced Biomedical Sciences, University Federico II of Naples
    • Contact: Giuseppe Gargiulo, MD, PhD; Email: giuseppe.gargiulo1@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1) Patients not providing consent to data collection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Number of patients with all-cause mortality	30 days, 1 year
Cardiovascular mortality	Number of patients with cardiovascular mortality	30 days, 1 year
Myocardial infarction	Number of patients with myocardial infarction	30 days, 1 year
Stent thrombosis	Number of patients with stent thrombosis	30 days, 1 year
Stroke	Number of patients with stroke	30 days, 1 year
Heart Failure	Number of patients with heart failure	30 days, 1 year
Hospitalization for heart failure	Number of patients with hospitalization for heart failure	30 days, 1 year
Bleeding	Number of patients with bleeding	30 days, 1 year
Acute kidney injury	Number of patients with acute kidney injury	30 days, 1 year
Target vessel revascularization	Number of patients with target vessel revascularization	30 days, 1 year
Target lesion revascularization	Number of patients with target lesion revascularization	30 days, 1 year
Hospital length of stay	Duration of hospitalization in days	0 to 30 days (or more depending on diration of hospitalization)
Metrics of diuretic response and decongestion	Diuresis quantification, weight loss, decongestion score, etc.	0 to 30 days (or more depending on diration of hospitalization)
Poor neurologic outcomes	Number of patients with poor neurologic outcomes	30 days, 1 year
ICCU length of stay	Duration of ICCU hospitalization in days	0 to 30 days (or more depending on diration of hospitalization)
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	0 to 30 days (or more depending on diration of hospitalization)
Quality of life	Quality of life assessment by various scores or questionnaires	30 days, 1 year

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Giuseppe Gargiulo, MD, PhD, Department of Advanced Biomedical Sciences; Study Chair: Giovanni Esposito, MD, PhD, Department of Advanced Biomedical Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Eur Heart J. 2024 Jan 1;45(1):53. doi: 10.1093/eurheartj/ehad613.
• 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. Erratum In: Eur Heart J. 2024 Apr 1;45(13):1145. doi: 10.1093/eurheartj/ehad870.
• 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. Erratum In: Eur Heart J Acute Cardiovasc Care. 2023 Feb 9;12(2):138. doi: 10.1093/ehjacc/zuac155.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): November 20, 2033
• Study Completion (Estimated): November 20, 2033

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Cardiovascular Diseases; Shock, Cardiogenic; Acute Coronary Syndrome
• Other Study ID Numbers: Naples FED2-ICCU Registry; CET Campania 3 86/2023 (Registry Identifier: Naples FED2-ICCU Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No