Hjerte MR-guidet deferipronterapi til patienter med akut myokardieinfarkt (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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Research Coordinator
- Telefonnummer: (317) 274-0985
- E-mail: csaha@iu.edu
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- IU Methodist Hospital (IUHealth)
-
Kontakt:
- Chandana Saha, PhD
- Telefonnummer: 317-274-0985
- E-mail: csaha@iu.edu
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55407
- Rekruttering
- Minneapolis Heart Institute Foundation
-
Ledende efterforsker:
- Jay Traverse, MD
-
Kontakt:
- Colleen Quinlan
- Telefonnummer: 763-688-7451
- E-mail: colleen.quinlan@allina.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Aktiv komparator: 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 komparator: 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 komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Efficacy
Tidsramme: 6 months
|
Percentage reduction of hemorrhagic zone iron content by cardiac magnetic resonance at 6 months relative to baseline |
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Effect: Clinical Outcomes of Acute Heart Failure
Tidsramme: 6 months
|
The proportion of subjects who experience an acute heart failure event |
6 months
|
|
Treatment Effect: Clinical Outcomes of Non-Fatal Cardiovascular morbidity
Tidsramme: 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
Tidsramme: 6 months
|
Rate of discontinuation of therapy due to side effects |
6 months
|
|
Safety and Tolerability - Severe Side Effects
Tidsramme: 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
Tidsramme: 6 months
|
Percentage of Reversible of Side Effects without treatment |
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment Effect: Fat Infiltration
Tidsramme: 6 months
|
Percentage difference of fat infiltration within the hemorrhagic myocardial infarction arms at 6 months between deferiprone and placebo groups |
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Rohan Dharmakumar, PhD, Medical Imaging Research Institute, Indiana University School of Medicine
- Ledende efterforsker: Keyur P Vora, MD FACP FACC, Medical Imaging Research Institute, Indiana University School of Medicine
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13487
- 2R01HL133407-05 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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