- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Ahmed Mostafa Mostafa
- Numer telefonu: +201158744246
- E-mail: ahmed1111mostafa@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: hager saideldin saideldin
- Numer telefonu: +201065099621
- E-mail: hagersaadeldin@gmail.com
Lokalizacje studiów
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Sohag, Egipt, 82511
- Sohag University Hospital
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Kontakt:
- Ahmed Mostafa Mostafa
- Numer telefonu: +201158744246
- E-mail: ahmed1111mostafa@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
patients indicated for coronary angiography in sohag university hospital
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: CROSS_SECTIONAL
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Association between Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Assessment of coronary blood flow using TIMI flow grade.
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Soh-Med-26-10-9MS
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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