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

A

Ain Shams University

Status and phase

Not yet enrolling
Phase 2

Conditions

Reperfusion Injury, Myocardial
Myocardial Infarction

Treatments

Drug: L-Carnitine
Drug: The standard care for the management of myocardial infarction post PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT06564909
RHDIRB2020110301 REC #268

Details and patient eligibility

About

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

Full 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

Enrollment

76 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

Control group
Experimental group
Description:
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.
Treatment:
Drug: The standard care for the management of myocardial infarction post PCI
Test group
Experimental group
Description:
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
Treatment:
Drug: The standard care for the management of myocardial infarction post PCI
Drug: L-Carnitine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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