Coronary Artery DiseaseNCT07356219
Prognostic Nutritional Index for Predicting Outcomes Following Coronary Artery Bypass Grafting (CABG) Surgery
An observational study of Coronary Artery Disease, run by Benha University at 1 site in Egypt.
Trial summary
Coronary artery bypass grafting (CABG) is a major cardiac surgery associated with risks of serious perioperative complications and mortality. Malnutrition and inflammation are known independent risk factors for poor outcomes in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR) and Body Mass Index (BMI)
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 20 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of adult patients (both male and female) who underwent major coronary artery bypass grafting surgery at the Cardiothoracic Surgery Department of Benha University Hospital within a recent five-year period.
Who may be able to join
- Patients who underwent CABG surgery.
- Availability of a signed informed consent form before surgery.
Who cannot join
- Other concurrent cardiac surgeries.
- Presence of malignancy or systemic inflammatory disorders.
- Active infection or autoimmune disorders.
- Maintenance on immunosuppressants.
- Liver disease.
- Files with missing data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Merits of the Prognostic Nutritional Index for Prediction of the Outcome of Coronary Artery Bypass Grafting Surgery: A Retrospective Observational Study
Coronary artery bypass grafting (CABG) is a major cardiac surgery associated with risks of serious perioperative complications and mortality. Malnutrition and inflammation are known independent risk factors for poor outcomes in patients with coronary artery disease. This retrospective observational study evaluates the Prognostic Nutritional Index (PNI)-a simple score derived from serum albumin and lymphocyte counts-as an objective measure of nutritional and inflammatory status. The research aims to determine how well preoperative PNI and its postoperative changes can predict complications such as acute kidney injury, myocardial infarction, and sternal wound infections in patients undergoing CABG.
- Conditions
- Coronary Artery Disease
- Being tested
- Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Body Mass Index (BMI)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognostic Nutritional Index (PNI)Diagnostic test
Calculated using serum albumin (g/L) and total peripheral lymphocyte count.
Neutrophil-to-Lymphocyte Ratio (NLR)Diagnostic test
Calculated from peripheral blood counts.
Body Mass Index (BMI)Diagnostic test
Calculated from preoperative weight and height.
| Study group | Role | What they receive |
|---|---|---|
| CABG Patient Cohort. | Patients who underwent Coronary Artery Bypass Grafting surgery at Benha University Hospital over the preceding five years. Receives: Diagnostic Test: Prognostic Nutritional Index (PNI); Diagnostic Test: Neutrophil-to-Lymphocyte Ratio (NLR); Diagnostic Test: Body Mass Index (BMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of the Prognostic Nutritional Index (PNI) in Predicting Post-CABG Complications.
The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the performance of the PNI score in predicting the occurrence of major postoperative complications.
Measured: Approximately 30 days (From surgery through the duration of the hospital/ICU stay.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Nov 2025
- Primary completion11 Jan 2026
- Study completion20 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Benha 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed El Gazzar, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356219
- Sponsor's protocol ID
- RC 6.11.2025
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2026
- Last updated
- 21 Jan 2026
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Merits of the Prognostic Nutritional Index for Prediction of the Outcome of Coronary Artery Bypass Grafting Surgery: A Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07356219
- Acronym / sponsor ID
- RC 6.11.2025
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 11 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
Coronary artery bypass grafting (CABG) is a major cardiac surgery associated with risks of serious perioperative complications and mortality. Malnutrition and inflammation are known independent risk factors for poor outcomes in patients with coronary artery disease. This retrospective observational study evaluates the Prognostic Nutritional Index (PNI)-a simple score derived from serum albumin and lymphocyte counts-as an objective measure of nutritional and inflammatory status. The research aims to determine how well preoperative PNI and its postoperative changes can predict complications such as acute kidney injury, myocardial infarction, and sternal wound infections in patients undergoing CABG.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG Patient Cohort. | – | Diagnostic Test: Prognostic Nutritional Index (PNI), Diagnostic Test: Neutrophil-to-Lymphocyte Ratio (NLR), Diagnostic Test: Body Mass Index (BMI)Patients who underwent Coronary Artery Bypass Grafting surgery at Benha University Hospital over the preceding five years. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of adult patients (both male and female) who underwent major coronary artery bypass grafting surgery at the Cardiothoracic Surgery Department of Benha University Hospital within a recent five-year period.
Key inclusion criteria (2 listed)
- Patients who underwent CABG surgery.
- Availability of a signed informed consent form before surgery.
Key exclusion criteria (6 listed)
- Other concurrent cardiac surgeries.
- Presence of malignancy or systemic inflammatory disorders.
- Active infection or autoimmune disorders.
- Maintenance on immunosuppressants.
- Liver disease.
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 |
|---|---|---|
| Prognostic Nutritional Index (PNI)Calculated using serum albumin (g/L) and total peripheral lymphocyte count. | Diagnostic test | CABG Patient Cohort. |
| Neutrophil-to-Lymphocyte Ratio (NLR)Calculated from peripheral blood counts. | Diagnostic test | CABG Patient Cohort. |
| Body Mass Index (BMI)Calculated from preoperative weight and height. | Diagnostic test | CABG Patient Cohort. |
Primary outcome
Diagnostic Accuracy of the Prognostic Nutritional Index (PNI) in Predicting Post-CABG Complications.
Time frame: Approximately 30 days (From surgery through the duration of the hospital/ICU stay.)
The Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) used to determine the performance of the PNI score in predicting the occurrence of major postoperative complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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 Coronary Artery Disease, run by Benha 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy of the Prognostic Nutritional Index (PNI) in Predicting Post-CABG Complications. (time frame: Approximately 30 days (From surgery through the duration of the hospital/ICU stay.)). 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 21 Jan 2026.