Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

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Description

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.

Study Overview

Start Date
November 8, 2022
Completion Date
July 1, 2025
Enrollment
72
Date Posted
November 3, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Krannert Cardiovascular Research Center
Indianapolis, Indiana 46202, United States

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria

Index 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) and
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
Elevated biomarkers (Troponin)
Coronary angiogram with primary PCI to occur irrespective of the duration of the symptoms.

Exclusion Criteria

Prior history of MI / PCI / CABG
Patients with history of LVEF < 40%
Use of investigational drugs or devices 30 days prior to randomization
Known allergy or contra-indication to gadolinium/contrast agents
eGFR < 30 ml/kg/min
Any 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 randomization
Body weight > 140 kg (or 309 lbs.)
Absolute neutrophil count of ANC < 1.0 x 109 /L
Elevated hepatic enzymes (ALT and/or AST) > 2 times of upper normal limit and not taking medications for chronic liver disease
Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators
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 LIPOMED.
Life expectancy of less than 1 year due to non-cardiac pathology

Study Contact Info

Study Contact Name
Chandana Saha, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
NCTid (if applicable)
NCT05604131