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

NCT06162247 · Federico II University
In plain English

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About this study
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).
Eligibility criteria
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
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-20
Estimated completion: 2033-11-20
Last updated: 2025-03-03
Primary outcomes
  • All-cause mortality (30 days, 1 year)
  • Cardiovascular mortality (30 days, 1 year)
  • Myocardial infarction (30 days, 1 year)
Sponsor
Federico II University · other
Contacts & investigators
ContactGiuseppe Gargiulo, MD, PhD · contact · giuseppe.gargiulo1@unina.it · +39-7462253
ContactGiovanni Esposito, MD, PhD · contact · espogiov@unina.it · +39-7463075
InvestigatorGiuseppe Gargiulo, MD, PhD · principal_investigator, Department of Advanced Biomedical Sciences
InvestigatorGiovanni Esposito, MD, PhD · study_chair, Department of Advanced Biomedical Sciences
All locations (1)
Department of Advanced Biomedical Sciences, University Federico II of NaplesRecruiting
Naples, Italy
Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry) · TrialPath