Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline Syndecan-1 concentration at 10th day
研究概览
简要总结
Severe SARS-CoV-2 disease is characterized by a progressive hypoxemic respiratory failure. Autopsies from these patients show severe endothelial damage with extensive vascular thrombosis, microangiopathy, and occlusion of alveolar capillaries and, finally, evidence of new vessel growth through intussusceptive angiogenesis.
This research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events.
详细描述
To study the presence of endothelial damage and angiogenic biomarkers with major cardiovascular events, the investigators will perform an observational study to evaluate plasma biomarkers concentrations in Covid-19 patients hospitalized in critical care units.
After ethical review board approval, the investigators will select 40 patients admitted to intensive care units (ICU). After patient written consent or if the participants are unable to consent, after a relative subrogated acceptance, the investigators will collect blood samples in the first 24 hrs and on the 10th day of hospitalization.
Venous blood samples are collected. After obtaining all samples, serum Syndecan-1, thrombomodulin, ANG-2, FGF basic, HGF, IL-8, PDGF-BB, TIMP-1, TIMP-2, TNFα y VEGF will be determined by a researcher blinded to the patient using commercially available Elisa kits. The concentration of each biomarker at each sample time will be compared. The investigators will observe clinical outcomes after one, 3, 6, and 12 months after the hospitalization.
The investigators found no previous data of this measurement in the COVID-19 scenario. In this observational study, the investigators select a sample size on convenience for the primary outcome.
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
- 是
入选标准
- •Patients older than 18 years
- •Patient with a diagnosis of COVID-19 confirmed by PCR
- •Patient with radiological image suggestive of COVID-19 with pending confirmation
- •Need for ventilatory support with oxygen therapy by HFNC (High-flow nasal cannula)
- •Need for invasive mechanical ventilation.
排除标准
- •Patient with an image suggestive of COVID-19 with negative PCR
- •Anticoagulation users before admission for any reason.
结局指标
主要结局
Change from Baseline Syndecan-1 concentration at 10th day
时间窗: 24 Hours, 10 Days
Elevation of plasma Syndecan-1
次要结局
- Change from Baseline ANG-2 concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline FGF basic concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline HGF concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline IL-8 concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline PDGF-BB concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline TIMP-1 concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline TIMP-2 concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline TNFα concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline VEGF concentration at 10th day(24 Hours, 10 Days)
- Change from Baseline Thrombomodulin concentration at 10th day(24 Hours, 10 Days)
- Major cardiovascular events(1 month, 3 months, 6 months 12 months.)
研究者
Felipe Andrés Maldonado Caniulao
Principal Investigator
University of Chile