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NCT Number: NCT06162247

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

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.

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Key information

Conditions

Acute Cardiovascular Disease Acute Coronary Syndrome Acute Heart Failure Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Advanced Biomedical Sciences, University Federico II of Naples

Naples, 80131, Italy

Location status: Recruiting

Location contact

Giuseppe Gargiulo, MD, PhD

CONTACT

[email protected]

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute cardiovascular disease admitted at our ICCU
  • Age ≥18 years;
  • Written informed consent.

Exclusion criteria

  • Patients not providing consent to data collection

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days, 1 year

    Number of patients with all-cause mortality

  2. Cardiovascular mortality

    Time frame: 30 days, 1 year

    Number of patients with cardiovascular mortality

  3. Myocardial infarction

    Time frame: 30 days, 1 year

    Number of patients with myocardial infarction

  4. Stent thrombosis

    Time frame: 30 days, 1 year

    Number of patients with stent thrombosis

  5. Stroke

    Time frame: 30 days, 1 year

    Number of patients with stroke

  6. Heart Failure

    Time frame: 30 days, 1 year

    Number of patients with heart failure

  7. Hospitalization for heart failure

    Time frame: 30 days, 1 year

    Number of patients with hospitalization for heart failure

  8. Bleeding

    Time frame: 30 days, 1 year

    Number of patients with bleeding

  9. Acute kidney injury

    Time frame: 30 days, 1 year

    Number of patients with acute kidney injury

  10. Target vessel revascularization

    Time frame: 30 days, 1 year

    Number of patients with target vessel revascularization

  11. Target lesion revascularization

    Time frame: 30 days, 1 year

    Number of patients with target lesion revascularization

  12. Hospital length of stay

    Time frame: 0 to 30 days (or more depending on diration of hospitalization)

    Duration of hospitalization in days

  13. Metrics of diuretic response and decongestion

    Time frame: 0 to 30 days (or more depending on diration of hospitalization)

    Diuresis quantification, weight loss, decongestion score, etc.

  14. Poor neurologic outcomes

    Time frame: 30 days, 1 year

    Number of patients with poor neurologic outcomes

  15. ICCU length of stay

    Time frame: 0 to 30 days (or more depending on diration of hospitalization)

    Duration of ICCU hospitalization in days

  16. Metrics of need for mechanical circulatory support and vasopressors/inotropes

    Time frame: 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

  17. Quality of life

    Time frame: 30 days, 1 year

    Quality of life assessment by various scores or questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Esposito, MD, PhD

CONTACT

[email protected]

+39-7463075

Giuseppe Gargiulo, MD, PhD

CONTACT

[email protected]

+39-7462253

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Dec 8, 2023
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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