NCT06564909

Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI

Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Reperfusion Injury, Myocardial
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	L-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)
DRUG	The 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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2024-08-21
• Last updated: 2025-06-26

Locations

1 site across 1 country: Egypt