- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05226377
Relation Between Atherogenic Index of COVID-19 and Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
High Atherogenic Index of Plasma At-admission of COVID-19 Patients Can Predict Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity
Time Frame: two weeks
|
Development of new cardiac insult
|
two weeks
|
|
Mortality
Time Frame: two weeks
|
Death of patients due to new cardiac insult
|
two weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35069/11/21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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