Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609332
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2020-10-23
Brief Title:
Endothelial Damage and Angiogenesis Biomarkers During COVID-19
Sponsor:
University of Chile
Organization:
University of Chile
Study Overview
Official Title:
Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
This research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None