Metformin Continuation Safety in Diabetic Patients Undergoing Coronary Angiography
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Increase in lactate of 20%
研究概览
简要总结
The present study aims to evaluate the strict application of the 2018 European Society of Cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately before angiography and withhold metformin if renal function deteriorates.
The aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.
详细描述
The study is designed as an open-label (both physician and participant know that metformin will not be discontinued before PCI and in the following 48 hours), prospective, single arm study.
In our historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l.
A total of 150 patients will be enrolled. Patients with any deviations from the study protocol will be enrolled in a parallel observational registry.
The study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. The total duration of participation in the study for each participant is approximately 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients treated with metformin undergoing coronary angiography.
排除标准
- •Known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 * estimated glomerular filtration rate; e.g.: 167 ml in a patients with an eGFR of 45 ml/min/1.73m2).
- •Moderate to severe impairment of renal function (eGFR<45 ml/min).
- •Moderate to severe impairment of liver function (Child-Pugh class B or C).
- •Severely impaired left ventricular ejection fraction (LVEF <35%).
- •Patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with ST elevation myocardial infarction).
- •Severe to very severe chronic obstructive pulmonary disease (GOLD class 3 to 4).
- •Patients scheduled for cardiac surgery in the following 5 days.
- •Inability to provide informed consent.
研究组 & 干预措施
Metformin continuation
干预措施: Metformin (Drug)
结局指标
主要结局
Increase in lactate of 20%
时间窗: From preprocedural values (same day of the coronary angiography) to 72 hours after coronary angiography
Lactate will be measured from a venous sampling at three different time points, before coronary angiography, the day after (not mandatory) and 3 days after coronary angiography
次要结局
- Contrast-associated acute kidney injury after coronary angiography.(From 0 to 7 days after coronary angiography)
- Metformin associated lactic acidosis(At 24 and 72 hours after coronary angiography)
研究者
Giulio Stefanini
Professor
Humanitas Hospital, Italy