- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Ahmed Mostafa Mostafa
- Telefonnummer: +201158744246
- E-post: ahmed1111mostafa@gmail.com
Studera Kontakt Backup
- Namn: hager saideldin saideldin
- Telefonnummer: +201065099621
- E-post: hagersaadeldin@gmail.com
Studieorter
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Sohag, Egypten, 82511
- Sohag University Hospital
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Kontakt:
- Ahmed Mostafa Mostafa
- Telefonnummer: +201158744246
- E-post: ahmed1111mostafa@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
patients indicated for coronary angiography in sohag university hospital
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Association between Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
|
|
Association between Triglyceride to High-Density Lipoprotein Cholesterol Ratio (TG/HDL-C) and coronary artery disease severity.
Tidsram: 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.
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Assessment of coronary blood flow using TIMI flow grade.
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Soh-Med-26-10-9MS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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