Cardiac EventNCT05040750
Correlation Between Cardiac Markers and Severity of COVID-19
An observational study of Cardiac Event, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cardiac Event
- What is being tested?
- laboratory investigation
- How many people
- 207 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: all moderate to severe COVID 19 patients who were admitted to ICU
Who may be able to join
- all moderate to severe COVID 19 patients who were admitted to ICU.
- Both genders
- age group 18-60 years
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiac Event
- Being tested
- laboratory investigation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory investigationOther
observe the relation between cardiac markers and mortality rate in critically ill COVID 19 patients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: laboratory investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between cardiac markers and mortality rate in critically ill COVID 19 patients
relate cardiac biomarkers to mortality rate
Measured: 4 month
Secondary outcomes (1)
relation ship between cardiac and inflammatory and coagulation markers
compare cardiac markers to inflammatory and coagulation laboratory findings
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, MD, Ain Shams University
- Investigators
- Fathy Tash, MD, Study chair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040750
- Sponsor's protocol ID
- FMASU R 150 / 2021
- Status last verified
- Oct 2024
- First submitted
- 9 Sep 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cardiac Markers and Severity of COVID-19 in Egyptian Population
- ClinicalTrials.gov ID
- NCT05040750
- Acronym / sponsor ID
- FMASU R 150 / 2021
- Conditions
- Cardiac Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| moderate to severe COVID 19 patients | – | Other: laboratory investigationmoderate 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- all moderate to severe COVID 19 patients who were admitted to ICU
Key inclusion criteria (3 listed)
- all moderate to severe COVID 19 patients who were admitted to ICU.
- Both genders
- age group 18-60 years
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory investigationobserve the relation between cardiac markers and mortality rate in critically ill COVID 19 patients | Other | moderate to severe COVID 19 patients |
Primary outcome
relation between cardiac markers and mortality rate in critically ill COVID 19 patients
Time frame: 4 month
relate cardiac biomarkers to mortality rate
1 secondary outcome
relation ship between cardiac and inflammatory and coagulation markers
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fathy Tash, MD study chair
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Event, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between cardiac markers and mortality rate in critically ill COVID 19 patients (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.