Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Target lesion revascularization
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute cardiovascular disease admitted at our ICCU
- •Age ≥18 years;
- •Written informed consent.
排除标准
- •Patients not providing consent to data collection
结局指标
主要结局
Target lesion revascularization
时间窗: 30 days, 1 year
Number of patients with target lesion revascularization
Myocardial infarction
时间窗: 30 days, 1 year
Number of patients with myocardial infarction
Stent thrombosis
时间窗: 30 days, 1 year
Number of patients with stent thrombosis
Metrics of diuretic response and decongestion
时间窗: 0 to 30 days (or more depending on diration of hospitalization)
Diuresis quantification, weight loss, decongestion score, etc.
Cardiovascular mortality
时间窗: 30 days, 1 year
Number of patients with cardiovascular mortality
Stroke
时间窗: 30 days, 1 year
Number of patients with stroke
Heart Failure
时间窗: 30 days, 1 year
Number of patients with heart failure
Quality of life
时间窗: 30 days, 1 year
Quality of life assessment by various scores or questionnaires
All-cause mortality
时间窗: 30 days, 1 year
Number of patients with all-cause mortality
Acute kidney injury
时间窗: 30 days, 1 year
Number of patients with acute kidney injury
Metrics of need for mechanical circulatory support and vasopressors/inotropes
时间窗: 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
Hospitalization for heart failure
时间窗: 30 days, 1 year
Number of patients with hospitalization for heart failure
Bleeding
时间窗: 30 days, 1 year
Number of patients with bleeding
Target vessel revascularization
时间窗: 30 days, 1 year
Number of patients with target vessel revascularization
Hospital length of stay
时间窗: 0 to 30 days (or more depending on diration of hospitalization)
Duration of hospitalization in days
Poor neurologic outcomes
时间窗: 30 days, 1 year
Number of patients with poor neurologic outcomes
ICCU length of stay
时间窗: 0 to 30 days (or more depending on diration of hospitalization)
Duration of ICCU hospitalization in days
次要结局
未报告次要终点
研究者
Giuseppe Gargiulo
Associate Professor
Federico II University