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

NCT06162247 | Recruiting

• 2 other identifiers: Naples FED2-ICCU RegistryCET Campania 3 86/2023
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Cardiovascular Disease; Acute Coronary Syndrome; Acute Heart Failure; Cardiogenic Shock

Outcome Measures

Primary Outcomes (17)

• 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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \) Patients not providing consent to data collection

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Advanced Biomedical Sciences, University Federico II of Naples

Napoli, 80131, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 37622654 BACKGROUND

• 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.

  PMID: 37622666 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 36259751 BACKGROUND

• 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.

  PMID: 36306949 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Giuseppe Gargiulo, MD, PhD

  Department of Advanced Biomedical Sciences

  PRINCIPAL INVESTIGATOR

• Giovanni Esposito, MD, PhD

  Department of Advanced Biomedical Sciences

  STUDY CHAIR

Central Study Contacts

Giuseppe Gargiulo, MD, PhD

CONTACT

+39-7462253; giuseppe.gargiulo1@unina.it

Giovanni Esposito, MD, PhD

CONTACT

+39-7463075; espogiov@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 8, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): November 20, 2033
• Study Completion (Estimated): November 20, 2033
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)