Impact of SGLT-2 Inhibitors on Renal Function Among the Patients Undergoing Percutaneous Coronary Interventions with Type 2 Diabetes and Coronary Artery Disease: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Serum creatinine values
研究概览
简要总结
Type 2 Diabetes Mellitus (T2DM) is a complex and challenging health issue. Twenty-five per cent of patients who undergo elective Percutaneous Coronary Intervention (PCI) have T2DM. In about 1.3 to 33.3% of patients, AKI is primarily attributed to the utilization of contrast medium. And considered as a primary contributing aspect to the development of acute kidney injury (AKI). Contrast agents cause direct toxicity, inflammation, elevated thrombogenic state and decreased renal perfusion among patients undergoing PCI procedures after myocardial infarction with T2DM [9-12]. These patients have a higher risk of developing CI-AKI. It is noted that 40% of the patients on SGLT2-i have a reduction in the progression of kidney disease. The pleiotropic effects of the SGLT2-i on kidney function may potentially reduce CI-AKI among T2DM with CAD conditions who are undergoing PCI procedures [16]. This study aims to evaluate the effect of SGLT2-i on renal function in individuals with coronary artery disease (CAD) and T2DM who are undergoing PCI.
This study is terminated as we were not able to recruit any study participants in the intervention group.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •>18 years Medication duration 3months.
- •3years T2DM with indication of PCI Obstructive coronary artery disease, characterized by a ≥50% narrowing in a major epicardial vessel, and who also have a clinical indication for undergoing PCI. Willing to provide consent to participate in the study eGFR range 50-90 ml/min/1.73m2.
排除标准
- •Auto immune disease Chronic use of anti-inflammatory medications.
- •Severe anemia Dialysis Cardiogenic shock Use of nephrotoxic drugs History of CIN Use of contrast media less than 7 days Pregnant.
结局指标
主要结局
Serum creatinine values
时间窗: At Baseline and 48 hours and 30 to 37 days
BUN
时间窗: At Baseline and 48 hours and 30 to 37 days
CI-AKI
时间窗: At Baseline and 48 hours and 30 to 37 days
Requirement of dialysis
时间窗: At Baseline and 48 hours and 30 to 37 days
eGFR
时间窗: At Baseline and 48 hours and 30 to 37 days
Requirement of Dialysis
时间窗: At Baseline and 48 hours and 30 to 37 days
Micro/macroalbuminuria
时间窗: At Baseline and 48 hours and 30 to 37 days
次要结局
- At Baseline, biomarkers elevation of creatine kinase MB CKMB less than or equal to 10 times the upper reference limit URL and troponin less than or equal to 70 times the upper reference limit URL within 24 hours after PCI.(ECG Echo)