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

Recruiting

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

• Registration Number: NCT06162247
• Lead Sponsor: Federico II University

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.

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 Timeline

• Study First Submitted: 2023-11-18
• Study Start: 2023-11-20
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2033-11-20
• Study Completion: 2033-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Advanced Biomedical Sciences, University Federico II of Naples; 🇮🇹 Napoli, Italy