Clinical trial NCT06564909: Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
Official title: Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Reperfusion Injury, Myocardial
Myocardial Infarction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the marker nitrotyrosine
timeFrame: 24 hours post PCI
measure: Evaluation of the marker (MMP-2)
timeFrame: 24 hours post PCI
Secondary outcomes:
measure: Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow
timeFrame: 0-1 hour at the end of PCI
measure: Assessment of Myocardial Blush Grade
timeFrame: 0-1 hour at the end of PCI
measure: Incidence of ST-segment resolution >70 by ECG
timeFrame: 60 minutes post PCI
measure: Echocardiography
timeFrame: 4 weeks
measure: Occurrence of Major Adverse Cardiac Events (MACE)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: