Insulin Resistance and Its Association With no Reflow Phenomenon After Primary PCI in Type II Diabetic STEMI Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Syntax score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Type 2 Diabetes Mellitus patients .
- •Undergoing PCI for STEMI.
- •Written informed consent obtained.
排除标准
- •1. Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
- •2. Individuals with Cardiogenic shock.
- •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.
- •Type 1 Diabetes Mellitus patients.
研究组 & 干预措施
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 :
- Individuals with a previous history of myocardial infarction (MI) or decompensated heart failure.
- Individuals with Cardiogenic shock.
- Individuals with a history of PCI or coronary artery bypass grafting (CABG).
- Previous familial mixed dyslipidemia / Hypertriglycerideemia (Homozygous or heterozygous).
- Patients with significant hepatic impairment (transaminase levels ≥ 2x normal value).
- Patients with renal impairment (GFR < 60 mL/min/1.73 m²).
- Active infection or inflammatory disease.
- Known autoimmune disease.
- Malignancy.
- Type 1 Diabetes Mellitus patients.
干预措施: PCI (Procedure)
结局指标
主要结局
Syntax score
时间窗: through study completion, an average of 2 year
1\. To assess the association between TyG index and SYNTAX score in patients with T2DM undergoing PCI.
No reflow phenomenon
时间窗: through study completion, an average of 2 year
2\. To evaluate the relationship between TyG index and the occurrence of the no-reflow phenomenon after PCI.
SYNTAX Score (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery Score)
时间窗: 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.
次要结局
- independent clinical and metabolic predictors(through study completion, an average of 2 year)
- MACEs(through study completion, an average of 2 year)
- Predictive value of the TYG index(through study completion, an average of 2 year)
- Area under the receiver operating characteristic (ROC) curve of the triglyceride-glucose (TyG) index for predicting the no-reflow phenomenon(through study completion, an average of 2 year)
研究者
Mohammed Ahmed Abd-Elhmied Mohammed
Assistant Lecturer of Critical Care Medicine, Department of Internal Medicine, Faculty of Medicine, Assiut University
Assiut University