NCT05604131 Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
| NCT ID | NCT05604131 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rohan Dharmakumar |
| Condition | Acute Myocardial Infarction Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 89 participants |
| Start Date | 2022-11-08 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 89 participants in total. It began in 2022-11-08 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.
Eligibility Criteria
Inclusion Criteria 1. Age 18-79 years 2. Index Anterior wall STEMI 3. Emergency coronary angiogram with primary PCI Exclusion Criteria 1. Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year 2. Patients with previous history of left ventricular ejection fraction (LVEF) \< 40% 3. Use of investigational drugs or devices 30 days prior to randomization 4. Known allergy or contra-indication to gadolinium/contrast agents 5. eGFR \< 30 ml/kg/min 6. Any contraindication against cardiac MRI (such as metal implants) 7. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization 8. Body weight \> 140 kg (or 309 lbs.) 9. Absolute neutrophil count - ANC \< 1.5 k/cumm 10. History of Chronic Liver Disease 11. Elevated hepatic enzymes (BOTH ALT and AST) \> 2 times of upper normal limit 12. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators 13. Any clinically significant abnormality identified prior to randomization that in the judgment of the Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone. 14. Life expectancy of less than 1 year due to non-cardiac pathology
Contact & Investigator
Keyur P Vora, MD FACP FACC
PRINCIPAL INVESTIGATOR
Medical Imaging Research Institute, Indiana University School of Medicine
Frequently Asked Questions
Who can join the NCT05604131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Acute Myocardial Infarction Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05604131 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05604131 currently recruiting?
Yes, NCT05604131 is actively recruiting participants. Contact the research team at csaha@iu.edu for enrollment information.
Where is the NCT05604131 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05604131 clinical trial?
NCT05604131 is sponsored by Rohan Dharmakumar. The principal investigator is Keyur P Vora, MD FACP FACC at Medical Imaging Research Institute, Indiana University School of Medicine. The trial plans to enroll 89 participants.