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| Name | Class |
|---|---|
| Minneapolis Heart Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorrhagic Myocardial Infarction - Deferiprone | Active Comparator | Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
|
| Non-hemorrhagic Myocardial Infarction - Deferiprone | Active Comparator | Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
|
| Hemorrhagic Myocardial Infarction - Placebo | Placebo Comparator | Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
|
| Non-hemorrhagic Myocardial Infarction - Placebo | Placebo Comparator | Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferiprone Tablets | Drug | Deferiprone tablets are the active medication for the active arm of the study groups. Randomization will be done by investigational drug services pharmacist and intervention will be double-blinded to investigators and patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy | Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect: Clinical Outcomes of Acute Heart Failure | The proportion of subjects who experience an acute heart failure event | 6 months |
| Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Effect: Fat Infiltration | Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups | 6 months |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | (317) 274-0985 | csaha@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keyur P Vora, MD FACP FACC | Medical Imaging Research Institute, Indiana University School of Medicine | Principal Investigator |
| Rohan Dharmakumar, PhD | Medical Imaging Research Institute, Indiana University School of Medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Methodist Hospital (IUHealth) | Recruiting | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23403335 | Background | Kali A, Kumar A, Cokic I, Tang RL, Tsaftaris SA, Friedrich MG, Dharmakumar R. Chronic manifestation of postreperfusion intramyocardial hemorrhage as regional iron deposition: a cardiovascular magnetic resonance study with ex vivo validation. Circ Cardiovasc Imaging. 2013 Mar 1;6(2):218-28. doi: 10.1161/CIRCIMAGING.112.000133. Epub 2013 Feb 12. | |
| 27903536 |
| Label | URL |
|---|---|
| CARDIO-THERANOSTICS is developing diagnostics and therapeutics for hemorrhagic myocardial infarction | View source |
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| ID | Term |
|---|---|
| D000077543 | Deferiprone |
| ID | Term |
|---|---|
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Deferiprone placebo is the non-medicated formulation for a control arm of the study groups. |
|
The proportion of subjects who experience other non-fatal cardiovascular morbidity such as recurrent myocardial infarction, ventricular arrhythmia and CVA
| 6 months |
| Safety and Tolerability - Rate of Discontinuation | Rate of discontinuation of therapy due to side effects | 6 months |
| Safety and Tolerability - Severe Side Effects | Rate of severe side effects requiring hospitalization, extension of length-of-stay. | 6 months |
| Safety and Tolerability - Reversibility of Side Effects without Treatment | Percentage of Reversible of Side Effects without treatment | 6 months |
| Kali A, Cokic I, Tang R, Dohnalkova A, Kovarik L, Yang HJ, Kumar A, Prato FS, Wood JC, Underhill D, Marban E, Dharmakumar R. Persistent Microvascular Obstruction After Myocardial Infarction Culminates in the Confluence of Ferric Iron Oxide Crystals, Proinflammatory Burden, and Adverse Remodeling. Circ Cardiovasc Imaging. 2016 Nov;9(11):e004996. doi: 10.1161/CIRCIMAGING.115.004996. |
| 29680356 | Background | Wang G, Yang HJ, Kali A, Cokic I, Tang R, Xie G, Yang Q, Francis J, Li S, Dharmakumar R. Influence of Myocardial Hemorrhage on Staging of Reperfused Myocardial Infarctions With T2 Cardiac Magnetic Resonance Imaging: Insights Into the Dependence on Infarction Type With Ex Vivo Validation. JACC Cardiovasc Imaging. 2019 Apr;12(4):693-703. doi: 10.1016/j.jcmg.2018.01.018. Epub 2018 Apr 18. |
| 34991787 | Background | Liu T, Howarth AG, Chen Y, Nair AR, Yang HJ, Ren D, Tang R, Sykes J, Kovacs MS, Dey D, Slomka P, Wood JC, Finney R, Zeng M, Prato FS, Francis J, Berman DS, Shah PK, Kumar A, Dharmakumar R. Intramyocardial Hemorrhage and the "Wave Front" of Reperfusion Injury Compromising Myocardial Salvage. J Am Coll Cardiol. 2022 Jan 4;79(1):35-48. doi: 10.1016/j.jacc.2021.10.034. |
| 27894072 | Background | Dharmakumar R. "Rusty Hearts": Is It Time to Rethink Iron Chelation Therapies in Post-Myocardial-Infarction Setting? Circ Cardiovasc Imaging. 2016 Oct;9(10):e005541. doi: 10.1161/CIRCIMAGING.116.005541. No abstract available. |
| 29242241 | Background | Dharmakumar R. Colors of Myocardial Infarction: Can They Predict the Future? Circ Cardiovasc Imaging. 2017 Dec;10(12):e007291. doi: 10.1161/CIRCIMAGING.117.007291. No abstract available. |
| 34368506 | Background | Dharmakumar R, Nair AR, Kumar A, Francis J. Myocardial Infarction and the Fine Balance of Iron. JACC Basic Transl Sci. 2021 Jul 26;6(7):581-583. doi: 10.1016/j.jacbts.2021.06.004. eCollection 2021 Jul. |
| 34261494 | Background | Guan X, Chen Y, Yang HJ, Zhang X, Ren D, Sykes J, Butler J, Han H, Zeng M, Prato FS, Dharmakumar R. Assessment of intramyocardial hemorrhage with dark-blood T2*-weighted cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jul 15;23(1):88. doi: 10.1186/s12968-021-00787-4. |
| 34587984 | Background | Chen Y, Ren D, Guan X, Yang HJ, Liu T, Tang R, Ho H, Jin H, Zeng M, Dharmakumar R. Quantification of myocardial hemorrhage using T2* cardiovascular magnetic resonance at 1.5T with ex-vivo validation. J Cardiovasc Magn Reson. 2021 Sep 30;23(1):104. doi: 10.1186/s12968-021-00779-4. |
| 23847253 | Background | Kali A, Tang RL, Kumar A, Min JK, Dharmakumar R. Detection of acute reperfusion myocardial hemorrhage with cardiac MR imaging: T2 versus T2. Radiology. 2013 Nov;269(2):387-95. doi: 10.1148/radiology.13122397. Epub 2013 Jul 11. |
| 26259581 | Background | Cokic I, Kali A, Yang HJ, Yee R, Tang R, Tighiouart M, Wang X, Jackman WS, Chugh SS, White JA, Dharmakumar R. Iron-Sensitive Cardiac Magnetic Resonance Imaging for Prediction of Ventricular Arrhythmia Risk in Patients With Chronic Myocardial Infarction: Early Evidence. Circ Cardiovasc Imaging. 2015 Aug;8(8):10.1161/CIRCIMAGING.115.003642 e003642. doi: 10.1161/CIRCIMAGING.115.003642. |
| 24066038 | Background | Cokic I, Kali A, Wang X, Yang HJ, Tang RL, Thajudeen A, Shehata M, Amorn AM, Liu E, Stewart B, Bennett N, Harlev D, Tsaftaris SA, Jackman WM, Chugh SS, Dharmakumar R. Iron deposition following chronic myocardial infarction as a substrate for cardiac electrical anomalies: initial findings in a canine model. PLoS One. 2013 Sep 16;8(9):e73193. doi: 10.1371/journal.pone.0073193. eCollection 2013. |
| 33264359 | Background | Nair AR, Johnson EA, Yang HJ, Cokic I, Francis J, Dharmakumar R. Reperfused hemorrhagic myocardial infarction in rats. PLoS One. 2020 Dec 2;15(12):e0243207. doi: 10.1371/journal.pone.0243207. eCollection 2020. |