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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
L-Carnitine 5 g intravenous administered as slow IV push over 2-3 minutes (L-Carnitine 1 gm / 5 mL Injection®, MEPACO, Egypt) and Carnitol 500 mg® Oral, Global Napi, Egypt)
include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
Ain Shams University Hospitals
Cairo, Egypt
RECRUITINGEvaluation of the marker nitrotyrosine
Measuring serum concentration of nitrotyrosine as an oxidative stress marker
Time frame: 24 hours post PCI
Evaluation of the marker (MMP-2)
Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
Time frame: 24 hours post PCI
Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow
Grade 0: No perfusion Grade 1: Penetration without perfusion Grade 2: Partial perfusion Grade 3: Complete perfusion
Time frame: 0-1 hour at the end of PCI
Assessment of Myocardial Blush Grade
Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush
Time frame: 0-1 hour at the end of PCI
Incidence of ST-segment resolution >70 by ECG
Time frame: 60 minutes post PCI
Echocardiography
Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes
Time frame: 4 weeks
Occurrence of Major Adverse Cardiac Events (MACE)
mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc
Time frame: 4 weeks
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