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.
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 Type
OBSERVATIONAL
Enrollment
5,000
Department of Advanced Biomedical Sciences, University Federico II of Naples
Naples, Italy
RECRUITINGAll-cause mortality
Number of patients with all-cause mortality
Time frame: 30 days, 1 year
Cardiovascular mortality
Number of patients with cardiovascular mortality
Time frame: 30 days, 1 year
Myocardial infarction
Number of patients with myocardial infarction
Time frame: 30 days, 1 year
Stent thrombosis
Number of patients with stent thrombosis
Time frame: 30 days, 1 year
Stroke
Number of patients with stroke
Time frame: 30 days, 1 year
Heart Failure
Number of patients with heart failure
Time frame: 30 days, 1 year
Hospitalization for heart failure
Number of patients with hospitalization for heart failure
Time frame: 30 days, 1 year
Bleeding
Number of patients with bleeding
Time frame: 30 days, 1 year
Acute kidney injury
Number of patients with acute kidney injury
Time frame: 30 days, 1 year
Target vessel revascularization
Number of patients with target vessel revascularization
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Time frame: 30 days, 1 year
Target lesion revascularization
Number of patients with target lesion revascularization
Time frame: 30 days, 1 year
Hospital length of stay
Duration of hospitalization in days
Time frame: 0 to 30 days (or more depending on diration of hospitalization)
Metrics of diuretic response and decongestion
Diuresis quantification, weight loss, decongestion score, etc.
Time frame: 0 to 30 days (or more depending on diration of hospitalization)
Poor neurologic outcomes
Number of patients with poor neurologic outcomes
Time frame: 30 days, 1 year
ICCU length of stay
Duration of ICCU hospitalization in days
Time frame: 0 to 30 days (or more depending on diration of hospitalization)
Metrics of need for mechanical circulatory support and vasopressors/inotropes
Need for MCS, MCS type and duration; need for vasopressors/inotropes, vasopressors/inotropes types and duration
Time frame: 0 to 30 days (or more depending on diration of hospitalization)
Quality of life
Quality of life assessment by various scores or questionnaires
Time frame: 30 days, 1 year