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

Sponsor
Ain Shams University
Study ID
NCT06564909
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myocardial Infarction
  • Reperfusion Injury, Myocardial

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • L-Carnitine — DRUG
    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)
  • The standard care for the management of myocardial infarction post PCI — DRUG
    include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.

Study Details

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

Key Dates

First listed
Aug 21, 2024
Start date
Jun 1, 2025
Status verified
Jun 2025
Primary completion
Feb 28, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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

Primary Outcome Measure

Evaluation of the marker nitrotyrosine [ Time Frame: 24 hours post PCI ]

Central Contacts

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