Incidence and Prognostic Implication of Acute Cardiovascular Events in Patients Hospitalized for Community-acquired Pneumonia in Internal Medicine Units.The FADOI-ICECAP Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,266
- 主要终点
- Incidence of CV events
研究概览
简要总结
FADOI-ICECAP is a observational, prospective, multicenter study involving 20-25 nationwide Units of Internal Medicine. The study foresees the participation of 26 Internal Medicine Operative Units, and for each of them a prospective registration of data relative to at least 50 patients admitted with CAP (in total, at least 1300 evaluable subjects) is foreseen.
详细描述
Phase 1 - Patients enrollment (October 2016 - February 2018) Each Investigator have recorded data concerning 50 patients. It will be collected general characteristics of patients, clinical parameters and conditions, diagnostic imaging and blood tests,
Phase 2 - Database review and validation (April 2018 - October 2018) The data collected will be analysed to process the endpoints.
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
- •Age > 18 years
- •Diagnosis of pneumonia defined by the presence on chest X-ray or CT-scan of lung of new infiltration associated with at least two of the following clinical features:
- •fever > 37.8°C
- •typical symptoms (dyspnea, productive cough, pain)
- •typical clinical signs on chest examination (crepitation, bronchial breathing, pleural effusion)
- •leukocytosis
排除标准
- •patients with Hospital-Acquired Pneumonia (HAP) (i.e. those patients with pneumonia acquired in hospital more than 48 hours after admission)
- •patients with tuberculosis in active phase
- •patients with cystic fibrosis
- •patients who refuse to participate in the study and/or to give the written informed consent.
结局指标
主要结局
Incidence of CV events
时间窗: 17 months
To assess the cumulative incidence of well defined acute CV complications during hospitalization for CAP (index event).
次要结局
- Mortality(18 months)
- Impact of acute CV events(18 months)
- Impact of CV events(18 months)
- Risk factor(18 months)
- Incidence of CV events in patients without history of heart failure, acute coronary syndrome, cerebrovascular disease, or clinically relevant arrhythmia(18 months)