Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Composite outcome
研究概览
简要总结
This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19.
The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death.
Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.
详细描述
This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization.
The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints.
The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.
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
- •Patients diagnosed with SARS-CoV-2
- •Recently admitted to the hospital (≤ 72 hours)
- •Not yet proceeded to ICU care
排除标准
- •Patients transferred from other hospitals
- •Participants in delirium state
- •Participants with a recent history of endotracheal intubation
结局指标
主要结局
Composite outcome
时间窗: Up to hospital discharge, an average of 4 weeks
A composite outcome including ICU admission, intubation and all-cause mortality
次要结局
- All-cause mortality(Up to hospital discharge, an average of 4 weeks)
- ICU admission(Up to hospital discharge, an average of 4 weeks)
- Intubation(Up to hospital discharge, an average of 4 weeks)
- Cardiovascular complications(Up to hospital discharge, an average of 4 weeks)