- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040750
Correlation Between Cardiac Markers and Severity of COVID-19
October 7, 2024 updated by: Rania Maher Hussien, MD, Ain Shams University
Correlation Between Cardiac Markers and Severity of COVID-19 in Egyptian Population
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.
Study Overview
Detailed 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
Study Type
Observational
Enrollment (Actual)
207
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 69711
- Ain shams university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
all moderate to severe COVID 19 patients who were admitted to ICU
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
moderate to severe COVID 19 patients
moderate to severe COVID 19 patients admitted to ICU.
Both genders within the age group 18-60 years were included.
Diagnosis of COVID 19 was confirmed
|
observe the relation between cardiac markers and mortality rate in critically ill COVID 19 patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
relation between cardiac markers and mortality rate in critically ill COVID 19 patients
Time Frame: 4 month
|
relate cardiac biomarkers to mortality rate
|
4 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
relation ship between cardiac and inflammatory and coagulation markers
Time Frame: 4 month
|
compare cardiac markers to inflammatory and coagulation laboratory findings
|
4 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fathy Tash, MD, Ain shams university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
July 30, 2023
Study Completion (Actual)
July 30, 2023
Study Registration Dates
First Submitted
September 9, 2021
First Submitted That Met QC Criteria
September 9, 2021
First Posted (Actual)
September 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 7, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU R 150 / 2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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