Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-Carnitine, The standard care for the management of myocardial infarction post PCI.
- Who it may be relevant to
- Registry conditions: Reperfusion Injury, Myocardial, Myocardial Infarction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug 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) - Drug 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.
Primary outcome measures
- Evaluation of the marker nitrotyrosine [Time frame: 24 hours post PCI]
- Evaluation of the marker (MMP-2) [Time frame: 24 hours post PCI]
Secondary outcome measures (5)
- Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow [Time frame: 0-1 hour at the end of PCI]
- Assessment of Myocardial Blush Grade [Time frame: 0-1 hour at the end of PCI]
- Incidence of ST-segment resolution >70 by ECG [Time frame: 60 minutes post PCI]
- Echocardiography [Time frame: 4 weeks]
- Occurrence of Major Adverse Cardiac Events (MACE) [Time frame: 4 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain Shams University Hospitals — Cairo
Identifiers
NCT: NCT06564909 · RHDIRB2020110301 REC #268