- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Mostafa Mostafa
- Número de teléfono: +201158744246
- Correo electrónico: ahmed1111mostafa@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: hager saideldin saideldin
- Número de teléfono: +201065099621
- Correo electrónico: hagersaadeldin@gmail.com
Ubicaciones de estudio
-
-
-
Sohag, Egipto, 82511
- Sohag University Hospital
-
Contacto:
- Ahmed Mostafa Mostafa
- Número de teléfono: +201158744246
- Correo electrónico: ahmed1111mostafa@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
patients indicated for coronary angiography in sohag university hospital
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
group 1 patients indicated for coronary angiography
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association between Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Periodo de tiempo: baseline, before coronary angiography, within the 2-hour assessment period.
|
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.
|
|
Association between Metabolic Score for Insulin Resistance (METS-IR) and coronary artery disease severity.
Periodo de tiempo: baseline, prior coronary angiography, within the 2-hour assessment period.
|
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.
|
|
Association between Triglyceride-Glucose (TyG) Index and coronary artery disease severity.
Periodo de tiempo: baseline, prior coronary angiography, within the 2-hour assessment period.
|
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.
Periodo de tiempo: Within 2 hours before coronary angiography
|
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
|
|
Assessment of coronary artery disease severity and anatomical complexity using SYNTAX score.
Periodo de tiempo: During coronary angiography
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of coronary blood flow using TIMI flow grade.
Periodo de tiempo: During coronary angiography
|
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:
|
During coronary angiography
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Soh-Med-26-10-9MS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .