L‑Carnitine to reduce heart muscle damage after an ST‑elevation heart attack
Effect of L-Carnitine on Biomarkers of Myocardial Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
PHASE2 · Ain Shams University · NCT06564909
This will try whether giving L‑Carnitine before and after primary PCI lowers blood markers of reperfusion injury in adults with STEMI.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06564909 on ClinicalTrials.gov |
What this trial studies
In a randomized, open‑label, controlled Phase 2 design, 76 adults with STEMI undergoing primary PCI are assigned 1:1 to standard care or standard care plus L‑carnitine. The treatment arm receives 5 g IV L‑carnitine before PCI and 2 g orally daily for 4 weeks. Primary biochemical outcomes are nitrotyrosine (oxidative stress) and MMP‑2 (fibrosis), with additional assessments of TIMI flow, myocardial blush grade, and echocardiographic parameters. The trial emphasizes biomarker changes and tolerability rather than long‑term clinical endpoints.
Who should consider this trial
Good fit: Adults aged 18–75 presenting with STEMI within 12 hours who are planned for primary PCI, without prior MI/PCI/CABG and without severe liver or renal impairment, are ideal candidates.
Not a fit: Patients with late presentation (>12 hours), unsuccessful PCI, prior cardiac surgery, severe hepatic or renal disease, pregnancy, active infection, or current use of antioxidant drugs are unlikely to benefit or to be eligible.
Why it matters
Potential benefit: If successful, L‑carnitine could reduce oxidative stress and limit fibrosis after reperfusion, potentially improving myocardial perfusion and cardiac function.
How similar studies have performed: Small clinical and animal studies have suggested L‑carnitine may reduce ischemia–reperfusion injury and improve biomarkers, but high‑quality definitive clinical evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo
- Ain Shams University Hospitals — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mohamed Hamdy Mohamedy
- Email: mohamed.hamdy.mh@outlook.com
- Phone: +201151189985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Reperfusion Injury, Myocardial, Myocardial Infarction