- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07706335
Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Successful restoration of epicardial coronary artery patency in acute myocardial infarction (AMI) does not always guarantee adequate myocardial tissue perfusion or effective salvage of ischemic myocardium. In a substantial proportion of patients, microvascular dysfunction persists despite successful recanalization after percutaneous coronary intervention (PCI), limiting the expected clinical benefit of reperfusion therapy. This condition, known as the no-reflow phenomenon, is characterized by inadequate myocardial perfusion in the absence of angiographic evidence of mechanical vessel obstruction. No-reflow occurs in 2-60% of patients with ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse ventricular remodeling, malignant arrhythmias, heart failure, and increased short- and long-term mortality.
Distal embolization of thrombus and plaque debris during PCI is a major mechanism underlying microvascular obstruction and no-reflow, emphasizing the importance of identifying high-risk coronary lesions before intervention. The SYNTAX score, an angiographic tool reflecting coronary lesion complexity, has been shown to predict clinical outcomes and the occurrence of no-reflow in patients undergoing PCI. Patients with type 2 diabetes mellitus (T2DM) represent a particularly vulnerable group, as they frequently exhibit more complex coronary lesions and a higher incidence of no-reflow.
Insulin resistance (IR) plays a central role in endothelial dysfunction, vascular inflammation, and atherothrombosis. The triglyceride-glucose (TyG) index, a simple and reliable surrogate of IR, has been associated with adverse cardiovascular outcomes and has recently been shown to predict the occurrence of no-reflow in STEMI patients with T2DM undergoing PCI.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohammed Ahmed Abdelhmied
- Número de teléfono: 01147349160
- Correo electrónico: abdelhmied22@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ahmed Mohammed Ali obiedallah
- Número de teléfono: Professor 0100755 6396
- Correo electrónico: abdelhmied22@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Type 2 Diabetes Mellitus patients .
- Undergoing PCI for STEMI.
- Written informed consent obtained.
Exclusion Criteria:
1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
2. Individuals with Cardiogenic shock. 3. Individuals with a history of PCI or coronary artery bypass grafting (CABG). 4.Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
5.Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
6.Patients with renal impairment (GFR < 60 mL/min/1.73 m²). 7.Active infection or inflammatory disease. 8.Known autoimmune disease. 9.Malignancy. 10. Type 1 Diabetes Mellitus patients.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Type 2 diabetic patient
Inclusion criteria: 1. Age ≥ 18 years 2.Type 2 Diabetes Mellitus patients . 3.Undergoing PCI for STEMI. 4.Written informed consent obtained. 2.4.5-Exclusion criteria :
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All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
No reflow phenomenon
Periodo de tiempo: through study completion, an average of 2 year
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2. To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
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through study completion, an average of 2 year
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SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
Periodo de tiempo: through study completion, an average of 2 year
|
Assessment of the association between the triglyceride-glucose (TyG) index and the SYNTAX score in patients with type 2 diabetes mellitus undergoing primary PCI for STEMI. Scale details: Minimum value: 0 Maximum value: No fixed maximum (the score is unbounded and increases according to the number, complexity, and location of coronary lesions). Interpretation: Higher SYNTAX scores indicate greater coronary artery disease complexity and worse angiographic severity. |
through study completion, an average of 2 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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MACEs
Periodo de tiempo: through study completion, an average of 2 year
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3. To assess the relationship between insulin resistance markers and in-hospital major adverse cardiac events (MACEs).
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through study completion, an average of 2 year
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Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon
Periodo de tiempo: through study completion, an average of 2 year
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The discriminatory performance of the TyG index for predicting the occurrence of the no-reflow phenomenon after primary PCI will be assessed by the area under the ROC curve (AUC), with the optimal cutoff value, sensitivity, specificity, positive predictive value, and negative predictive value reported.
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through study completion, an average of 2 year
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.
- Pathak R, Hauer-Jensen M. Particle Beam may have Higher Effectiveness in Treating Chemo-resistant Cancers than Low-LET Photon Beam Therapy. Res Rev J Pharm Pharm Sci. 2015 Apr-Jun;4(2):1-2. Epub 2015 Jun 14. No abstract available.
- Xie X, Tang B, Zhou J, Gao Q, Zhang P. Inhibition of the PI3K/Akt pathway increases the chemosensitivity of gastric cancer to vincristine. Oncol Rep. 2013 Aug;30(2):773-82. doi: 10.3892/or.2013.2520. Epub 2013 Jun 5.
- Matza D, Badou A, Jha MK, Willinger T, Antov A, Sanjabi S, Kobayashi KS, Marchesi VT, Flavell RA. Requirement for AHNAK1-mediated calcium signaling during T lymphocyte cytolysis. Proc Natl Acad Sci U S A. 2009 Jun 16;106(24):9785-90. doi: 10.1073/pnas.0902844106. Epub 2009 Jun 2.
- Kacerova S, Muchova M, Doudova H, Munster L, Hanulikova B, Valaskova K, Kasparkova V, Kuritka I, Humpolicek P, Vichova Z, Vasicek O, Vicha J. Chitosan/dialdehyde cellulose hydrogels with covalently anchored polypyrrole: Novel conductive, antibacterial, antioxidant, immunomodulatory, and anti-inflammatory materials. Carbohydr Polym. 2024 Mar 1;327:121640. doi: 10.1016/j.carbpol.2023.121640. Epub 2023 Nov 28.
- Liu J, Teh WL, Tan RHS, Chang SSH, Lau BJ, Chandwani N, Tor PC, Subramaniam M. Evaluating a maladaptive personality-informed model of social support and post-traumatic stress disorder. J Affect Disord. 2024 Sep 15;361:209-216. doi: 10.1016/j.jad.2024.05.164. Epub 2024 May 29.
- Calafate S, Ozturan G, Thrupp N, Vanderlinden J, Santa-Marinha L, Morais-Ribeiro R, Ruggiero A, Bozic I, Rusterholz T, Lorente-Echeverria B, Dias M, Chen WT, Fiers M, Lu A, Vlaeminck I, Creemers E, Craessaerts K, Vandenbempt J, van Boekholdt L, Poovathingal S, Davie K, Thal DR, Wierda K, Oliveira TG, Slutsky I, Adamantidis A, De Strooper B, de Wit J. Early alterations in the MCH system link aberrant neuronal activity and sleep disturbances in a mouse model of Alzheimer's disease. Nat Neurosci. 2023 Jun;26(6):1021-1031. doi: 10.1038/s41593-023-01325-4. Epub 2023 May 15.
Fechas de registro del estudio
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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
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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
- noreflow in STEMI
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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