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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05040750
Other study ID # FMASU R 150 / 2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date July 30, 2023

Study information

Verified date February 2023
Source Ain Shams University
Contact Rania M Hussien, MD
Phone 026213948
Email drrania_maamon@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

By July 9, 2020, the global pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection had resulted in over 11.8 million confirmed cases and over 545000 deaths. Patients with a history of cardiovascular disease are especially vulnerable and have a bad prognosis. According to the findings, cardiac injury manifested by cardiac biomarker elevation is detected in a significant number of COVID-19 patients and is linked to poor outcomes and mortality. However, it is unclear how effective cardiac biomarkers are in COVID-19 prognosis and how to use these indicators.


Description:

The pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has led to >11.8 million confirmed cases with >545000 deaths worldwide by July 9, 2020 Patients with preexisting cardiovascular conditions are particularly at risk and have poor prognosis data suggest that cardiac injury, manifested by cardiac biomarker elevation, is detected in a sizable of COVID-19 patients and is associated with adverse outcomes and increased mortality. However, how useful cardiac biomarkers are in COVID-19 prognosis and how to utilize these markers have not been well defined The study will include all moderate to severe COVID 19 patients admitted to ICU. Both genders within the age group 18-60 years were included. The primary outcome is the relation between cardiac markers and mortality rate in critically ill COVID 19 patients The secondary outcome is the relationship between cardiac and inflammatory and coagulation markers


Recruitment information / eligibility

Status Recruiting
Enrollment 207
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - all moderate to severe COVID 19 patients who were admitted to ICU. - Both genders - age group 18-60 years Exclusion Criteria: - a refusal to participate in the study, - pregnant patients, - patients aged <18 or >60. years, - recent history of acute myocardial infarction (< 1 month before admission).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
laboratory investigation
observe the relation between cardiac markers and mortality rate in critically ill COVID 19 patients

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary relation between cardiac markers and mortality rate in critically ill COVID 19 patients relate cardiac biomarkers to mortality rate 4 month
Secondary relation ship between cardiac and inflammatory and coagulation markers compare cardiac markers to inflammatory and coagulation laboratory findings 4 month
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