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

ConditionsReperfusion Injury, MyocardialMyocardial Infarction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female or male aged >18 and < 75 years.

STEMI patients undergoing PCI.

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Control groupExperimental treatment 1 intervention
Group B: Test groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Evaluation of the marker nitrotyrosine

Measuring serum concentration of nitrotyrosine as an oxidative stress marker

Time frame
24 hours post PCI
2

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

Secondary outcomes

1

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
2

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
3

Incidence of ST-segment resolution >70 by ECG

Time frame
60 minutes post PCI
4

Echocardiography

Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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