Cardio-protective Effect of Metformin in Patients Undergoing Elective Percutaneous Coronary Intervention
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Postprocedural myocardial injury
研究概览
简要总结
This is a two-arm randomized parallel study. Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study.
The whole study protocol were presented to the local institutional review board (IRB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Adult patients (age above 18)
- •Undergoing elective PCI
排除标准
- •Hypersensitivity to metformin or any component of the formulation
- •Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.
- •Patients diagnosed with type 1 or 2 diabetes mellitus.
- •Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
- •Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
- •Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).
- •Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).
- •Need for coronary artery bypass grafting.
- •Participation in other clinical trial in the 30 days before enrollment.
- •The existence of a life-threatening disease with a life-expectancy of less than 6 months.
研究组 & 干预措施
Metformin Group
Patients will receive pre-treatment standard and post treatment of care to the procedure plus metformin 500 mg twice daily 7 days before and 6 months after the PCI procedure.
Metformin will be stopped on the same day of the procedure and restored 3 hours after the procedure.
干预措施: Metformin (Drug)
结局指标
主要结局
Postprocedural myocardial injury
时间窗: 6 months
the occurrence of postprocedural myocardial injury, defined as a postprocedural elevation of CKMB or cTnI more than 1 times the 99 th percentile of the URL \[ 24 hours post PCI\]
次要结局
- cTn(24 hours post PCI)
- LVEF in percent(Baseline- 6 months)
- Rate of hospitalization(through study completion, an average of 6 months)
- CK-MB(24 hours post PCI)
- Incidence of Cardiovascular Event(Baseline - 6 months)
- GFR(Baseline- monthly- 6 months)
- LVMI in g/m2(Baseline- 6 months)
- Serum creatinine (SCr)(Baseline- monthly- 6 months)
- Lactate concentration(Baseline - 6 months)
- Glucometabolic State(Baseline - 6 months)
研究者
Radwa Abdelatif
Principal Investigator
Future University in Egypt