Reperfusion Injury, MyocardialPhase 2NCT06564909
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With STEMI
A Phase 2 study testing L-Carnitine in people with Reperfusion Injury, Myocardial and Myocardial Infarction, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Reperfusion Injury, Myocardial, Myocardial Infarction
- What is being tested?
- L-Carnitine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged >18 and < 75 years.
- STEMI patients undergoing PCI.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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:
- Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
- Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
- 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
- Being tested
- L-Carnitine, The standard care for the management of myocardial infarction post PCI
- Medical subject headings
- Myocardial Reperfusion Injury, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDrug
Also called levocarnitine
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 PCIDrug
Also called Guideline-directed medical therapy for STEMI
include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: The standard care for the management of myocardial infarction post PCI |
| 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 Receives: Drug: L-Carnitine; Drug: The standard care for the management of myocardial infarction post PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the marker nitrotyrosine
Measuring serum concentration of nitrotyrosine as an oxidative stress marker
Measured: 24 hours post PCI
Evaluation of the marker (MMP-2)
Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
Measured: 24 hours post PCI
Secondary outcomes (5)
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
Measured: 0-1 hour at the end of PCI
Assessment of Myocardial Blush Grade
Grade 0: No myocardial blush Grade 1: Minimal myocardial blush Grade 2: Moderate myocardial blush Grade 3: Normal myocardial blush
Measured: 0-1 hour at the end of PCI
Incidence of ST-segment resolution >70 by ECG
Measured: 60 minutes post PCI
Echocardiography
Assessment of Left Ventricular Ejection Fraction (LVEF) and left ventricular diastolic and systolic volumes
Measured: 4 weeks
Occurrence of Major Adverse Cardiac Events (MACE)
mortality, rehospitalization, reinfarction, arrhythmias, arrest, etc
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reperfusion Injury, MyocardialStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed H. Mohamedy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564909
- Sponsor's protocol ID
- RHDIRB2020110301 REC #268
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06564909
- Acronym / sponsor ID
- RHDIRB2020110301 REC #268
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Measurement of nitrotyrosine as an oxidative stress marker and Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
- Assessment of The TIMI (thrombolysis in myocardial infarction) grade and Myocardial Blush Grade (MBG).
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: The standard care for the management of myocardial infarction post PCI38 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 | Drug: L-Carnitine, Drug: The standard care for the management of myocardial infarction post PCI38 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female or male aged >18 and < 75 years.
- STEMI patients undergoing PCI.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CarnitineAlso: levocarnitineL-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 | Test group |
| The standard care for the management of myocardial infarction post PCIAlso: Guideline-directed medical therapy for STEMIinclude the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations. | Drug | Control group, Test group |
Primary outcome
Evaluation of the marker nitrotyrosine
Time frame: 24 hours post PCI
Measuring serum concentration of nitrotyrosine as an oxidative stress marker
Evaluation of the marker (MMP-2)
Time frame: 24 hours post PCI
Measuring serum concentration of Matrix metallopeptidase-2 (MMP-2) as a cardiac fibrosis marker.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-Carnitine in people with Reperfusion Injury, Myocardial and Myocardial Infarction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the marker nitrotyrosine (time frame: 24 hours post PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.