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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
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | 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. |
|
| Test group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the marker nitrotyrosine | Measuring serum concentration of nitrotyrosine as an oxidative stress marker | 24 hours post PCI |
| Evaluation of the marker (MMP-2) | Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker. | 24 hours post PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Thrombolysis in Myocardial Infarction (TIMI) flow | Grade 0: No perfusion Grade 1: Penetration without perfusion Grade 2: Partial perfusion Grade 3: Complete perfusion | 0-1 hour at the end of PCI |
| Assessment of Myocardial Blush Grade |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Hamdy Mohamedy | Contact | +201151189985 | mohamed.hamdy.mh@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D015428 | Myocardial Reperfusion Injury |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| 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. |
|
|
Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush
| 0-1 hour at the end of PCI |
| Incidence of ST-segment resolution >70 by ECG | 60 minutes post PCI |
| Echocardiography | Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes | 4 weeks |
| Occurrence of Major Adverse Cardiac Events (MACE) | mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc | 4 weeks |
| D014652 |
| Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |