Cardiale MRI-geleide deferiprontherapie voor patiënten met een acuut myocardinfarct (MIRON-DFP)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Patients with newly diagnosed STEMI (ST-segment elevation myocardial infarction) who appear to meet eligibility criteria will be recruited for participation. Those who agree to participate and are confirmed to be eligible will undergo a cardiac MRI scan and will be randomized to take either deferiprone or placebo daily for 60 days. Total study participation will last 6 months, during which study participants will attend 7 study visits for blood draws, ECGs, and a repeat cardiac MRI at Day 180.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Clinical Research Coordinator
- Telefoonnummer: (317) 274-0985
- E-mail: csaha@iu.edu
Studie Locaties
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten, 46202
- Werving
- IU Methodist Hospital (IUHealth)
-
Contact:
- Chandana Saha, PhD
- Telefoonnummer: 317-274-0985
- E-mail: csaha@iu.edu
-
-
Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Werving
- Minneapolis Heart Institute Foundation
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Hoofdonderzoeker:
- Jay Traverse, MD
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Contact:
- Colleen Quinlan
- Telefoonnummer: 763-688-7451
- E-mail: colleen.quinlan@allina.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria
- At least 18 years of age
- Index Anterior wall STEMI
- Emergency coronary angiogram with primary PCI
Exclusion Criteria
- Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year
- Patients with previous history of left ventricular ejection fraction (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 - ANC < 1.5 k/cumm
- History of Chronic Liver Disease
- Elevated hepatic enzymes (BOTH ALT and AST) > 2 times of upper normal limit
- 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 deferiprone.
- Life expectancy of less than 1 year due to non-cardiac pathology
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Hemorrhagic Myocardial Infarction - Deferiprone
Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
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. |
|
Actieve vergelijker: Non-hemorrhagic Myocardial Infarction - Deferiprone
Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
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. |
|
Placebo-vergelijker: Hemorrhagic Myocardial Infarction - Placebo
Enrolled patients with CMR confirmed presence of intramyocardial hemorrhage |
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups. |
|
Placebo-vergelijker: Non-hemorrhagic Myocardial Infarction - Placebo
Enrolled patients with CMR confirmed absence of intramyocardial hemorrhage |
Deferiprone placebo is the non-medicated formulation for a control arm of the study groups. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment Efficacy
Tijdsspanne: 6 months
|
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline |
6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment Effect: Clinical Outcomes of Acute Heart Failure
Tijdsspanne: 6 months
|
The proportion of subjects who experience an acute heart failure event |
6 months
|
|
Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity
Tijdsspanne: 6 months
|
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
Tijdsspanne: 6 months
|
Rate of discontinuation of therapy due to side effects |
6 months
|
|
Safety and Tolerability - Severe Side Effects
Tijdsspanne: 6 months
|
Rate of severe side effects requiring hospitalization, extension of length-of-stay. |
6 months
|
|
Safety and Tolerability - Reversibility of Side Effects without Treatment
Tijdsspanne: 6 months
|
Percentage of Reversible of Side Effects without treatment |
6 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Treatment Effect: Fat Infiltration
Tijdsspanne: 6 months
|
Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups |
6 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rohan Dharmakumar, PhD, Medical Imaging Research Institute, Indiana University School of Medicine
- Hoofdonderzoeker: Keyur P Vora, MD FACP FACC, Medical Imaging Research Institute, Indiana University School of Medicine
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13487
- 2R01HL133407-05 (Subsidie/contract van de Amerikaanse NIH)
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