COVID-19NCT05226377
Relation Between Atherogenic Index of COVID-19 and Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
An observational study of COVID-19, run by Tanta University at 1 site in Egypt.
Trial summary
Plasma lipids levels were estimated and the Atherogenic Index of Plasma (AIP) was computed in 302 COVID confirmed patients. Patients were evaluated using the COVID-GRAM (CG) critical illness score and during a hospital stay the rates of admission to intensive care unit (ICU), development of cardiac insults, and need… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Atherogenic Index of Plasma
- How many people
- 302 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Mar 2021to 1 Sep 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: COVID confirmed patients free of Cardiac Diseases evaluated Clinically by laboratory investigations
Who may be able to join
- Only non-cardiac patients with confirmed COVID-19 disease who had mild-to-severe COVID disease according to the guidelines of the National Institutes of Health admitted to quarantine hospitals and free of exclusion criteria were enrolled in the study. Patients were categorized according to disease severity into mild, moderate, and severe.
Who cannot join
- Patients presented by COVID disease of critical severity that necessitated admission to ICU at time of hospital attendance, admission to ICU for any other indication, presence of a history of cardiac diseases, previous cardiothoracic or chest surgery for any indication, BMI of ≥35 kg/m2, presence of endocrinopathy, preexisting autoimmune diseases, current maintenance on immunosuppressive drugs, malignancy elsewhere in body organs, refusal to sign the written consent to receive the study protocol or death just on admission or before completion of the diagnostic protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Atherogenic Index of Plasma At-admission of COVID-19 Patients Can Predict Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
Plasma lipids levels were estimated and the Atherogenic Index of Plasma (AIP) was computed in 302 COVID confirmed patients. Patients were evaluated using the COVID-GRAM (CG) critical illness score and during a hospital stay the rates of admission to intensive care unit (ICU), development of cardiac insults, and need for admission to cardiac ICU (CCU) and its outcome were determined.
Read the detailed description
All patients were admitted to the quarantine department at Tanta University hospital and quarantine hospitals at Al-Gharbia governorate with a diagnosis of SERS-CoV-19 infection that was confirmed by having positive nasopharyngeal swab for SARS-CoV-2 using reverse transcriptase-polymerase chain reaction (RT-PCR). The study protocol was approved by the Local Ethical Committee according to instructions of the Ministry of Health and written informed consents were signed by all enrolled patients or their nearest relative.
Using the strict personal protective equipment, patients were clinically examined for collection of the demographic data age, sex, weight and height, history taking especially past and/or present history of diabetes mellitus (DM), hypertension, cardiac diseases, hypercoagulability events, chest, liver or kidney diseases or endocrinopathy. BMI was calculated in kg/m2 as weight (kg)/height (m2) (14) and was graded according to the guidelines of WHO (15). The chest was examined clinically and CT imaging was performed to assess the disease severity.
Clinical parameters
- COVID-19 disease severity grading
- COVID-GRAM Critical Illness Risk Score
- Atherogenic index of plasma (AIP)
Laboratory investigations A- Routine lab investigations included estimation of random blood glucose, complete blood count and serum levels of urea, creatinine, liver enzymes, and total and direct bilirubin B- Investigations for evaluation of SARS-CoV-2 infection severity including estimation of serum C-reactive protein, interleukin-6, lactate dehydrogenase, D-dimer levels.
C- Estimation of a plasma lipid profile
- Conditions
- COVID-19
- Being tested
- Atherogenic Index of Plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atherogenic Index of PlasmaDiagnostic test
- The atherogenic index of plasma (AIP) is defined as the base 10 logarithms of the ratio of plasma triglyceride (TG) to high-density lipoprotein cholesterol (HDL-c) (17). AIP was employed as a predictor of cardiac risk (CR) with values of -0.3 to 0.1 are associated with low, values of 0.1-0.24 are associated with the medium, and values above 0.24 with high CR
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Development of new cardiac insult
Measured: two weeks
Mortality
Death of patients due to new cardiac insult
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start7 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Tanta 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Fayez Al-kassas, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226377
- Sponsor's protocol ID
- 35069/11/21
- Status last verified
- Feb 2022
- First submitted
- 21 Jan 2022
- Last updated
- 7 Feb 2022
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Atherogenic Index of Plasma At-admission of COVID-19 Patients Can Predict Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
- ClinicalTrials.gov ID
- NCT05226377
- Acronym / sponsor ID
- 35069/11/21
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 7 Feb 2022 (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.
Plasma lipids levels were estimated and the Atherogenic Index of Plasma (AIP) was computed in 302 COVID confirmed patients. Patients were evaluated using the COVID-GRAM (CG) critical illness score and during a hospital stay the rates of admission to intensive care unit (ICU), development of cardiac insults, and need for admission to cardiac ICU (CCU) and its outcome were determined.
Detailed description
All patients were admitted to the quarantine department at Tanta University hospital and quarantine hospitals at Al-Gharbia governorate with a diagnosis of SERS-CoV-19 infection that was confirmed by having positive nasopharyngeal swab for SARS-CoV-2 using reverse transcriptase-polymerase chain reaction (RT-PCR). The study protocol was approved by the Local Ethical Committee according to instructions of the Ministry of Health and written informed consents were signed by all enrolled patients or their nearest relative.
Using the strict personal protective equipment, patients were clinically examined for collection of the demographic data age, sex, weight and height, history taking especially past and/or present history of diabetes mellitus (DM), hypertension, cardiac diseases, hypercoagulability events, chest, liver or kidney diseases or endocrinopathy. BMI was calculated in kg/m2 as weight (kg)/height (m2) (14) and was graded according to the guidelines of WHO (15). The chest was examined clinically and CT imaging was performed to assess the disease severity.
Clinical parameters
- COVID-19 disease severity grading
- COVID-GRAM Critical Illness Risk Score
- Atherogenic index of plasma (AIP)
Laboratory investigations A- Routine lab investigations included estimation of random blood glucose, complete blood count and serum levels of urea, creatinine, liver enzymes, and total and direct bilirubin B- Investigations for evaluation of SARS-CoV-2 infection severity including estimation of serum C-reactive protein, interleukin-6, lactate dehydrogenase, D-dimer levels.
C- Estimation of a plasma lipid profile
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- COVID confirmed patients free of Cardiac Diseases evaluated Clinically by laboratory investigations
Key inclusion criteria (1 listed)
- Only non-cardiac patients with confirmed COVID-19 disease who had mild-to-severe COVID disease according to the guidelines of the National Institutes of Health admitted to quarantine hospitals and free of exclusion criteria were enrolled in the study. Patients were categorized according to disease severity into mild, moderate, and severe.
Key exclusion criteria (1 listed)
- Patients presented by COVID disease of critical severity that necessitated admission to ICU at time of hospital attendance, admission to ICU for any other indication, presence of a history of cardiac diseases, previous cardiothoracic or chest surgery for any indication, BMI of ≥35 kg/m2, presence of endocrinopathy, preexisting autoimmune diseases, current maintenance on immunosuppressive drugs, malignancy elsewhere in body organs, refusal to sign the written consent to receive the study protocol or death just on admission or before completion of the diagnostic protocol.
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 |
|---|---|---|
| Atherogenic Index of Plasma- The atherogenic index of plasma (AIP) is defined as the base 10 logarithms of the ratio of plasma triglyceride (TG) to high-density lipoprotein cholesterol (HDL-c) (17). AIP was employed as a predictor of cardiac risk (CR) with values of -0.3 to 0.1 are associated with low, values of 0.1-0.24 are associated with the medium, and values above 0.24 with high CR | Diagnostic test | – |
Primary outcome
Morbidity
Time frame: two weeks
Development of new cardiac insult
Mortality
Time frame: two weeks
Death of patients due to new cardiac insult
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 7 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19, run by Tanta 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 1 inclusion and 1 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 7 Feb 2022. 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?
Morbidity (time frame: two weeks). The study lists 2 primary outcomes in all. 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 7 Feb 2022.