Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
- Conditions
- Reperfusion Injury, MyocardialMyocardial Infarction
- Interventions
- Drug: The standard care for the management of myocardial infarction post PCI
- Registration Number
- NCT06564909
- Lead Sponsor
- Ain Shams University
- Brief Summary
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
- Detailed Description
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:
1. Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
2. Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
3. 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:
Group 1 (Control group) (n=38): STEMI patients undergoing PCI who will receive the standard of care Group 2 (Test group) (n= 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 76
- Female or male aged >18 and < 75 years.
- STEMI patients undergoing PCI.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group The standard care for the management of myocardial infarction post PCI 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 Control group The standard care for the management of myocardial infarction post PCI 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. Test group L-Carnitine 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
- Primary Outcome Measures
Name Time Method Evaluation of the marker nitrotyrosine 24 hours post PCI Measuring serum concentration of nitrotyrosine as an oxidative stress marker
Evaluation of the marker (MMP-2) 24 hours post PCI Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
- Secondary Outcome Measures
Name Time Method Echocardiography 4 weeks Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes
Occurrence of Major Adverse Cardiac Events (MACE) 4 weeks mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc
Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow 0-1 hour at the end of PCI Grade 0: No perfusion Grade 1: Penetration without perfusion Grade 2: Partial perfusion Grade 3: Complete perfusion
Assessment of Myocardial Blush Grade 0-1 hour at the end of PCI Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush
Incidence of ST-segment resolution >70 by ECG 60 minutes post PCI