Myocardial Infarction, Reperfusion Injury, Myocardial
Conditions
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
Interventions
DRUGL-Carnitine
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)
DRUGThe standard care for the management of myocardial infarction post PCI
include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female or male aged \>18 and \< 75 years. * STEMI patients undergoing PCI.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
Countries
Egypt
Outcome results
None listed