Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
NCT ID: NCT06564909
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
76 participants
INTERVENTIONAL
2025-06-01
2026-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
The standard care for the management of myocardial infarction post PCI
include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
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
L-Carnitine
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
include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
Interventions
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L-Carnitine
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* STEMI patients undergoing PCI.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mohamed H. Mohamedy
Teaching assistant at clinical pharmacy department
Locations
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Ain Shams University Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RHDIRB2020110301 REC #268
Identifier Type: -
Identifier Source: org_study_id
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