Acute Cardiovascular Disease, Acute Coronary Syndrome, Acute Heart Failure, Cardiogenic Shock
Conditions
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).
Interventions
None listed
Sponsors
Federico II University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 days, 1 year | Number of patients with all-cause mortality |
| Cardiovascular mortality | 30 days, 1 year | Number of patients with cardiovascular mortality |
| Myocardial infarction | 30 days, 1 year | Number of patients with myocardial infarction |
| Stent thrombosis | 30 days, 1 year | Number of patients with stent thrombosis |
| Stroke | 30 days, 1 year | Number of patients with stroke |
| Heart Failure | 30 days, 1 year | Number of patients with heart failure |
| Hospitalization for heart failure | 30 days, 1 year | Number of patients with hospitalization for heart failure |
| Bleeding | 30 days, 1 year | Number of patients with bleeding |
| Acute kidney injury | 30 days, 1 year | Number of patients with acute kidney injury |
| Target vessel revascularization | 30 days, 1 year | Number of patients with target vessel revascularization |
| Target lesion revascularization | 30 days, 1 year | Number of patients with target lesion revascularization |
| Hospital length of stay | 0 to 30 days (or more depending on diration of hospitalization) | Duration of hospitalization in days |
| Metrics of diuretic response and decongestion | 0 to 30 days (or more depending on diration of hospitalization) | Diuresis quantification, weight loss, decongestion score, etc. |
| Poor neurologic outcomes | 30 days, 1 year | Number of patients with poor neurologic outcomes |
| ICCU length of stay | 0 to 30 days (or more depending on diration of hospitalization) | Duration of ICCU hospitalization in days |
| Metrics of need for mechanical circulatory support and vasopressors/inotropes | 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 |
| Quality of life | 30 days, 1 year | Quality of life assessment by various scores or questionnaires |
Countries
Italy
Contacts
Primary ContactGiuseppe Gargiulo, MD, PhD
Backup ContactGiovanni Esposito, MD, PhD
Outcome results
None listed