Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Evaluation of the marker nitrotyrosine
研究概览
简要总结
The study aims is to evaluate the efficacy and tolerability of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker
详细描述
This study aims to investigate the effects of L-Carnitine on biomarkers of myocardial reperfusion injury in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI by the assessment of the following:
- Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
- Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
- Echocardiography parameters
Patients and Methods:
Design: Prospective, randomized, open label, controlled clinical trial
Patients: A total of 76 STEMI patients undergoing primary PCI will be enrolled in the study and will be randomly assigned into one of 2 arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged >18 and < 75 years.
- •STEMI patients undergoing PCI.
排除标准
- •Patients with a recent history of myocardial infarction (MI), a previous PCI, a previous coronary artery bypass graft, or any cardiac surgery.
- •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,
- •Concurrent Infectious or active inflammatory disease,
- •Severe liver or renal disease, (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3x ULN or Total bilirubin > 3 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 antioxidant drugs.
- •History of or known allergy or intolerability to the study medications
研究组 & 干预措施
Test group
38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI
干预措施: L-Carnitine (Drug)
Control group
38 STEMI patients undergoing PCI who will receive the standard of care for 4 weeks and 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 the management of myocardial infarction post PCI (Drug)
Test group
38 STEMI patients undergoing PCI who will receive the standard of care in addition to L-Carnitine 5 g intravenous administered as slow Iv push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) prior to PCI and then 2 g orally (Carnitol 500 mg®, Global Napi, Egypt) daily for 4 weeks after PCI
干预措施: The standard care for the management of myocardial infarction post PCI (Drug)
结局指标
主要结局
Evaluation of the marker nitrotyrosine
时间窗: 24 hours post PCI
Measuring serum concentration of nitrotyrosine as an oxidative stress marker
Evaluation of the marker (MMP-2)
时间窗: 24 hours post PCI
Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
次要结局
- Echocardiography(4 weeks)
- Occurrence of Major Adverse Cardiac Events (MACE)(4 weeks)
- Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow(0-1 hour at the end of PCI)
- Assessment of Myocardial Blush Grade(0-1 hour at the end of PCI)
- Incidence of ST-segment resolution >70 by ECG(60 minutes post PCI)
研究者
Mohamed H. Mohamedy
Teaching assistant at clinical pharmacy department
Ain Shams University