Overview

Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

Status:
Recruiting

Trial end date:
2025-04-30

Target enrollment:
0

Participant gender:
All

Summary

The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free unbound iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rohan Dharmakumar

Collaborators:

Cardio-theranostics LLC
Lipomed AG

Treatments:

Deferiprone

Criteria

Inclusion Criteria

1. Index Anterior wall STEMI, based on American Heart Association guidelines diagnostic
criteria:

1. Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw
pain, arm pain, diaphoresis, or any anginal equivalent) and

2. ECG: New or presumed new ST-segment elevation at the J point in two or more
contiguous leads with the cut-off points ≥0.2 mV in leads V1, V2, V3, or V4 and ≥
0.1 mV in other leads

3. Elevated biomarkers (Troponin)

2. Coronary angiogram with primary PCI to occur irrespective of the duration of the
symptoms.

Exclusion Criteria

1. Prior history of MI / PCI / CABG

2. Patients with history of 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 of ANC < 1.0 x 109 /L

10. Elevated hepatic enzymes (SGPT/ SGLT > 2 times of upper normal limit)

11. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already
treated with iron chelators

12. Any clinically significant abnormality identified prior to randomization that in the
judgment of the Investigator or Sponsor would preclude safe completion of the study or
confound the anticipated benefit of LIPOMED.

13. Life expectancy of less than 1 year due to non-cardiac pathology