Actively Recruiting

Age: 18Years +
All Genders
ID06162247

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

Led by Federico II University · Updated on 2025-03-03

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective observational study to evaluate the current epidemiology, management, and clinical outcomes of patients with acute cardiovascular diseases admitted to the Intensive Cardiac Care Unit (ICCU) at the University Hospital Federico II. The focus is on conditions such as acute cardiovascular disease, acute coronary syndrome, acute heart failure, and cardiogenic shock. This study aims to collect comprehensive data to better understand patient care and outcomes without introducing new treatments. The study does not involve any experimental treatments or procedures but observes the usual guideline-directed care provided in the ICCU. Data collection includes demographic, clinical, procedural, therapeutic, and outcome information from patient admission onward. Follow-ups occur during the hospital stay, and at 30 days, 1 year, and the longest available period, through telephone or visits. An independent clinical events committee will review the main clinical outcomes. Participants will provide informed consent upon admission, after which all relevant data will be gathered and anonymized using a secure electronic system. Outcomes assessed include mortality, heart attacks, strokes, heart failure events, bleeding, kidney injury, length of hospital stay, use of mechanical support, neurological status, and quality of life at various time points. The study is overseen by the Clinical Trial Unit at the University of Naples Federico II, ensuring careful data management and patient follow-up until the study's end in 2033.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Acute cardiovascular disease admitted at the Intensive Cardiac Care Unit (ICCU)
  • Age 18 years or older
  • Ability and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Patients who do not provide consent to data collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 1 year or longer depending on follow-up

Participants who undergo routine care in the Intensive Cardiac Care Unit are observed. Data including demographic, clinical, procedural, therapeutic, and outcome information is collected during the hospital stay and through follow-up assessments.

In-hospital assessments plus follow-up visits or telephone calls at 30 days, 1 year, and longest available follow-up

Trial Site Locations

Total: 1 location

1

Department of Advanced Biomedical Sciences, University Federico II of Naples

Naples, Italy, 80131

Actively Recruiting

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Research Team

G

Giuseppe Gargiulo, MD, PhD

G

Giovanni Esposito, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure.

Theresa A McDonagh, Marco Metra, Marianna Adamo...

https://pubmed.ncbi.nlm.nih.gov/37622666

Cohort profile: the ESC EURObservational Research Programme Non-ST-segment elevation myocardial infraction (NSTEMI) Registry.

Ramesh Nadarajah, Peter Ludman, Yolande Appelman...

https://pubmed.ncbi.nlm.nih.gov/36259751