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This Phase Ila trial evaluates whether the intravenous administration of Dexrazoxane can reduce permanent heart muscle damage in patients undergoing standard stent procedures (PCI) for a severe heart attack (STEMI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexrazoxane Infusion | Experimental | Participants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI. |
|
| Placebo Infusion | Placebo Comparator | Participants receive an intravenous infusion of Normal Saline (0.9% NaCl) - visually identical to the investigational product - in the emergency room prior to primary PCI, followed by doses at 4, 8, and 12 hours post-primary PCI, adjunctive to standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexrazoxane | Drug | Intravenous infusion administered adjunctively to primary PCI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | Global left ventricular systolic function expressed as a percentage, quantified by steady-state free-precession cine CMR | 48-72 hours post-primary PCI |
| Intramyocardial Haemorrhage Burden (IMH %LV) | Volume of intramyocardial haemorrhage expressed as a percentage of total left ventricular myocardial mass, quantified by multi-echo T2*-weighted gradient-echo CMR | 48-72 hours post-primary PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Infarct Size (Infarct %LV) | Infarct size expressed as a percentage of total left ventricular myocardial mass, quantified by phase-sensitive inversion-recovery late gadolinium enhancement CMR. | 48-72 hours post-primary PCI |
| Microvascular Obstruction (MVO %LV) |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular Ejection Fraction (RVEF) | Global right ventricular systolic function expressed as a percentage, derived from contiguous short-axis SSFP cine CMR. | 48-72 hours post-primary PCI |
| High-Sensitivity Cardiac Troponin-I (hs-cTnI) |
Inclusion Criteria -
Exclusion Criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Keyur P Vora, MD MS FACC | Indiana University | Principal Investigator |
| Rohan Dharmakumar, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Cardiovascular Research Center | Rajkot | India |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D064730 | Dexrazoxane |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011929 | Razoxane |
| D054659 | Diketopiperazines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Twenty-five participants received intravenous Dexrazoxane adjunctive to primary PCI. Subsequently, 25 matched participants were prospectively enrolled as a control cohort from the same institution matched on culprit artery and ischemic determinants. Primary CMR endpoints assessed by independent blinded core laboratory at Indiana University School of Medicine.
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| Normal Saline |
| Drug |
Visually identical placebo infusion (Normal Saline 0.9% NaCl) of similar volume administered adjunctively to primary percutaneous coronary intervention (PCI). Administered at four timepoints: emergency room (pre-PCI), 4 hours, 8 hours, and 12 hours post-primary PCI, identical in appearance, volume, and schedule to the investigational product. |
|
MVO expressed as a percentage of total left ventricular myocardial mass, identified as a hypointense core region within the LGE-defined infarct zone on late gadolinium enhancement CMR. |
| 48-72 hours post-primary PCI |
Serial hs-cTnI concentrations (ng/L) measured at pre-specified timepoints: -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 16, 20, 24, and 48 hours relative to primary PCI.
| -1 hour pre-PCI through 48 hours post-primary PCI |
| Incidence of Major Bleeding (BARC Criteria) | Bleeding complications assessed using Bleeding Academic Research Consortium (BARC) criteria types 1-5. | First dose through 30 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006571 |
| Heterocyclic Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |