Clinical trial NCT06162247: Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
Official title: Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Cardiovascular Disease
Acute Coronary Syndrome
Acute Heart Failure
Cardiogenic Shock
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days, 1 year
measure: Cardiovascular mortality
timeFrame: 30 days, 1 year
measure: Myocardial infarction
timeFrame: 30 days, 1 year
measure: Stent thrombosis
timeFrame: 30 days, 1 year
measure: Stroke
timeFrame: 30 days, 1 year
measure: Heart Failure
timeFrame: 30 days, 1 year
measure: Hospitalization for heart failure
timeFrame: 30 days, 1 year
measure: Bleeding
timeFrame: 30 days, 1 year
measure: Acute kidney injury
timeFrame: 30 days, 1 year
measure: Target vessel revascularization
timeFrame: 30 days, 1 year
measure: Target lesion revascularization
timeFrame: 30 days, 1 year
measure: Hospital length of stay
timeFrame: 0 to 30 days (or more depending on diration of hospitalization)
measure: Metrics of diuretic response and decongestion
timeFrame: 0 to 30 days (or more depending on diration of hospitalization)
measure: Poor neurologic outcomes
timeFrame: 30 days, 1 year
measure: ICCU length of stay
timeFrame: 0 to 30 days (or more depending on diration of hospitalization)
measure: Metrics of need for mechanical circulatory support and vasopressors/inotropes
timeFrame: 0 to 30 days (or more depending on diration of hospitalization)
measure: Quality of life
timeFrame: 30 days, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Department of Advanced Biomedical Sciences, University Federico II of Naples
Study officials:
affiliation: Department of Advanced Biomedical Sciences
name: Giuseppe Gargiulo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Advanced Biomedical Sciences
name: Giovanni Esposito, MD, PhD
role: STUDY_CHAIR
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