Evaluation of The Effect of Alpha Lipoic Acid Administration on Oxidative Stress Markers and Occurrence of No-Reflow Phenomenon in Post Myocardial Infarction Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Occurrence of No-Reflow phenomena
研究概览
简要总结
Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.
详细描述
All (70) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 35 patients undergoing PCI who will receive standard of care , the other 35 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 4 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 4 week after PCI.
Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. will be documented for each patient. Medication history in detail, as well as the background cardiovascular treatment, will be considered.
All patients will be followed up regularly during the hospital stay and after discharge, will be assessed for the occurrence of adverse cardiac events and occurrence of adverse effects from medications
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
- 否
入选标准
- •Female or male aged >18
- •STEMI patients undergoing PCI
排除标准
- •Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
- •A late presentation (>12 h), unsuccessful primary PCI (residual stenosis >50% in the culprit lesion after procedure)
- •Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
- •Infectious or inflammatory disease
- •Severe liver or renal disease, (AST or ALT >3x ULN or Total bilirubin >2.5 x ULN), (CrCl < 60 ml/min (based on the Cockroft-Gault equation)
- •Neoplasm, or hematological disorders
- •Pregnant or breast-feeding patients
- •Active participation in another clinical study
- •Patients taking Alpha Lipoic Acid.
- •Systolic Blood pressure <90
研究组 & 干预措施
Control group
35 STEMI patients undergoing PCI who will receive standard of care that will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
干预措施: The standard care for post-PCI MI (Drug)
Test group
35 STEMI patients undergoing PCI who will receive the standard of care in addition to IV Alpha Lipoic Acid 600 mg before PCI then 600 mg orally for 28 days after PCI
干预措施: Alpha Lipoic Acid plus the standard care for post-PCI MI (Dietary Supplement)
结局指标
主要结局
Occurrence of No-Reflow phenomena
时间窗: During 1 week post PCI
To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients
次要结局
- Evaluation of markers that reflect oxidative stress and inflammation.(Baseline, 24 hours, and 7 days post PCI)
- Occurrence of MACE.(up to 4 weeks post PCI.)
- Tolerability of Alpha Lipoic Acid administration(During 4 week post PCI)
研究者
Omar Ragab
Dr.Omar Ragab
Ain Shams University