- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07928336
Comparison Between Different Insulin Resistance Markers and Their Correlation With Severity of Coronary Artery Disease in Non-diabetic Patients.
This study aims to investigate the association between insulin resistance (IR) and coronary artery disease (CAD) in non-diabetic patients. Furthermore, it evaluates the predictive value of multiple insulin resistance indices - specifically, the homeostatic model assessment for insulin resistance (HOMA-IR), Metabolic score for insulin resistance (METS-IR), Triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio, and triglyceride and glucose (TyG) index, as non-invasive markers of coronary artery disease severity. The diagnostic performance of these indices will be compared among patients with suspected CAD undergoing coronary angiography at the cardiac catheterization unit at Sohag University Hospital.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Mostafa Mostafa
- Phone Number: +201158744246
- Email: ahmed1111mostafa@gmail.com
Study Contact Backup
- Name: hager saideldin saideldin
- Phone Number: +201065099621
- Email: hagersaadeldin@gmail.com
Study Locations
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Sohag, Egypt, 82511
- Sohag University Hospital
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Contact:
- Ahmed Mostafa Mostafa
- Phone Number: +201158744246
- Email: ahmed1111mostafa@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
patients indicated for coronary angiography in sohag university hospital
Description
Inclusion Criteria:
- Aged ≥18 year.
- Both sexes
- Non-diabetic patients based on glycosylated hemoglobin (HbA1c) .
- Patient with Ischemic heart disease indicated for coronary angiography.
Exclusion Criteria:
- Patients age less than 18 years old.
- Insulin dependent diabetes
- Pregnant women
- End-stage renal disease on dialysis.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: CROSS_SECTIONAL
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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group 1 patients indicated for coronary angiography
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evaluates the predictive value of multiple insulin resistance indices - specifically, the homeostatic model assessment for insulin resistance (HOMA-IR), Metabolic score for insulin resistance (METS-IR), Triglyceride to high-density lipoprotein cholesterol (TG/HDL-C) ratio, and triglyceride and glucose (TyG) index, as non-invasive markers of coronary artery disease severity. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association between Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time Frame: baseline, before coronary angiography, within the 2-hour assessment period.
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Insulin resistance will be assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated as fasting plasma glucose and fasting insulin levels according to the following formula: HOMA-IR = [FPG (mg/dL) x fasting insulin (microU/mL)] / 405. Results will be reported as a continuous, dimensionless index; higher values indicate greater insulin resistance. The association between HOMA-IR and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade. |
baseline, before coronary angiography, within the 2-hour assessment period.
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Association between Metabolic Score for Insulin Resistance (METS-IR) and coronary artery disease severity.
Time Frame: baseline, prior coronary angiography, within the 2-hour assessment period.
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METS-IR will be calculated according to the following formula: Ln[(2 × fasting plasma glucose (mg/dL)) + fasting triglycerides (mg/dL)] × body mass index (kg/m²) ÷ Ln[HDL-cholesterol (mg/dL)]. Biochemical parameters will be derived from fasting venous blood collected before coronary angiography. Higher scores indicate greater insulin resistance. The association between METS-IR and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade. |
baseline, prior coronary angiography, within the 2-hour assessment period.
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Association between Triglyceride-Glucose (TyG) Index and coronary artery disease severity.
Time Frame: baseline, prior coronary angiography, within the 2-hour assessment period.
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The TyG index will be calculated according to the following formula: Ln[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL) ÷ 2], using blood samples collected before coronary angiography. The index is dimensionless and serves as a surrogate marker of insulin resistance, with higher values indicating greater resistance. The association between TyG index and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade. |
baseline, prior coronary angiography, within the 2-hour assessment period.
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Association between Triglyceride to High-Density Lipoprotein Cholesterol Ratio (TG/HDL-C) and coronary artery disease severity.
Time Frame: Within 2 hours before coronary angiography
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The TG/HDL-C ratio will be calculated according to the following formula: fasting serum triglycerides (mg/dL) divided by fasting serum HDL-cholesterol (mg/dL), using blood samples collected before coronary angiography. The ratio is dimensionless and serves as a surrogate marker of insulin resistance, with higher values indicating greater resistance. The association between TG/HDL-C ratio and coronary artery disease severity will be evaluated using coronary angiographic findings, including SYNTAX score and TIMI flow grade. |
Within 2 hours before coronary angiography
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Assessment of coronary artery disease severity and anatomical complexity using SYNTAX score.
Time Frame: During coronary angiography
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The anatomical complexity and severity of coronary artery disease will be assessed using the SYNTAX score calculated from coronary angiographic images. The SYNTAX score will be calculated based on the number, location, and anatomical characteristics of coronary lesions with diameter stenosis of at least 50% in coronary vessels with a reference diameter of at least 1.5 mm. The total numerical score will be reported; higher scores indicate greater anatomical complexity. Categories are low (≤22), intermediate (23-32), and high (≥33). The relationship between SYNTAX score and the four insulin resistance markers (HOMA-IR, METS-IR, TyG index, and TG/HDL-C ratio) will be evaluated. |
During coronary angiography
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of coronary blood flow using TIMI flow grade.
Time Frame: During coronary angiography
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Coronary blood flow in all major coronary arteries will be assessed during coronary angiography using the Thrombolysis in Myocardial Infarction (TIMI) flow grading system. Coronary blood flow will be classified into four grades:
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During coronary angiography
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Soh-Med-26-10-9MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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