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Recruiting
NCT05604131
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
Conditions: Acute Myocardial Infarction Type 1
Sex: All
Ages: 18 Years – 75 Years
Phase: PHASE1
Enrollment: 60
Sponsor: Rohan Dharmakumar
Location: United States
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.
Eligibility Criteria
Inclusion CriteriaIndex Anterior wall STEMI, based on American Heart Association guidelines diagnostic criteria:Symptoms of myocardial ischemia (such as chest pain, shortness of breath, jaw pain, arm pain, diaphoresis, or any anginal equivalent) andECG: 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 leadsElevated biomarkers (Troponin)Coronary angiogram with primary PCI to occur irrespective of the duration of the symptoms.Exclusion CriteriaPrior history of MI / PCI / CABGPatients with history of LVEF < 40%Use of investigational drugs or devices 30 days prior to randomizationKnown allergy or contra-indication to gadolinium/contrast agentseGFR < 30 ml/kg/minAny contraindication against cardiac MRI (such as metal implants)Women who are pregnant or breastfeeding.
Women of reproductive potential must have a negative pregnancy test prior to randomizationBody weight > 140 kg (or 309 lbs.)Absolute neutrophil count of ANC < 1.0 x 109 /LElevated hepatic enzymes (SGPT/ SGLT > 2 times of upper normal limit)Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelatorsAny 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.Life expectancy of less than 1 year due to non-cardiac pathology
Source: ClinicalTrials.gov (NCT05604131). StuddyBuddy aggregates publicly available trial information.