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NCT Number: NCT06564909

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

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

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Key information

Conditions

Reperfusion Injury, Myocardial Cardiomyopathies Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Myocardial Reperfusion Injury Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Location status: Recruiting

Location contact

Ayman Saleh, Professor

CONTACT

[email protected]

About this study

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:

  • Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
  • Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: levocarnitine

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.

Other names: Guideline-directed medical therapy for STEMI

Primary outcomes

  1. Evaluation of the marker nitrotyrosine

    Time frame: 24 hours post PCI

    Measuring serum concentration of nitrotyrosine as an oxidative stress marker

  2. Evaluation of the marker (MMP-2)

    Time frame: 24 hours post PCI

    Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.

Secondary outcomes

  1. Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow

    Time frame: 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

  2. Assessment of Myocardial Blush Grade

    Time frame: 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

  3. Incidence of ST-segment resolution >70 by ECG

    Time frame: 60 minutes post PCI

  4. Echocardiography

    Time frame: 4 weeks

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

  5. Occurrence of Major Adverse Cardiac Events (MACE)

    Time frame: 4 weeks

    mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Hamdy Mohamedy

CONTACT

[email protected]

+201151189985

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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