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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162247
• Other study ID #: Naples FED2-ICCU Registry
• Secondary ID: CET Campania 3 8
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: November 20, 2033

Study information

• Verified date: December 2023
• Source: Federico II University
• Contact: Giuseppe Gargiulo, MD, PhD
• Phone: +39-7462253
• Email: giuseppe.gargiulo1[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: November 20, 2033
• Est. primary completion date: November 20, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cardiovascular Disease
• Acute Coronary Syndrome
• Acute Heart Failure
• Cardiogenic Shock
• Cardiovascular Diseases
• Shock, Cardiogenic

Locations

Country	Name	City	State
Italy	Department of Advanced Biomedical Sciences, University Federico II of Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Nov 23;: — View Citation

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. — View Citation

Outcome

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