PCI
ProcedureAll eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
NCT Number: NCT07706335
To investigate the relationship between the TyG index, coronary lesion complexity assessed by the SYNTAX score, and the development of the no-reflow phenomenon in STEMI patients with T2DM.
Trial opening soon.
Get Notified18 year–100 year
All sexes
Observational
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
All eligible patients presenting with ST-segment elevation myocardial infarction (STEMI) will undergo primary percutaneous coronary intervention (PPCI)
Time frame: 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.
Time frame: through study completion, an average of 2 year
Time frame: through study completion, an average of 2 year
Time frame: through study completion, an average of 2 year
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.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
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