Acute Myocardial Infarction (AMI)
Conditions
Keywords
Hemorrhagic Myocardial Infarction, Primary Percutaneous Coronary Intervention, Cardiac Magnetic Resonance, Intramyocardial Hemorrhage, ST Elevation Myocardial Infarction, Acute Myocardial Infarction
Brief summary
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).
Interventions
DRUGDexrazoxane
Intravenous infusion administered adjunctively to primary PCI
DRUGNormal Saline
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.
Sponsors
Rohan Dharmakumar
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
- 1. Adult (18 - 79 years). 2. First STEMI (EMS/ER ECG ST-elevation) with primary PCI planned. 3. Consent pathway available: Patient consent, Legally Acceptable Representative (LAR) 4. CMR likely be feasible (no known MRI-unsafe implant or absolute MRI prohibition)
Exclusion criteria
- 1. History of PCI or CABG within 1 year 2. Known dialysis/ESRD 3. Known pre-existing LVEF \<40% from recent records 4. Known pregnancy or breastfeeding (history or clearly documented) 5. Current anthracycline chemotherapy or active chest radiation (per patient/chart). 6. On iron chelation now or documented iron-storage disease (hemochromatosis/thalassemia). 7. Concurrent trials: investigational drug or device use within 90 days. 8. Any clinically significant condition identified that would preclude safe peri-procedural administration of Dexrazoxane or completion of core protocol procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | 48-72 hours post-primary PCI | Global left ventricular systolic function expressed as a percentage, quantified by steady-state free-precession cine CMR |
| Intramyocardial Haemorrhage Burden (IMH %LV) | 48-72 hours post-primary PCI | Volume of intramyocardial haemorrhage expressed as a percentage of total left ventricular myocardial mass, quantified by multi-echo T2\*-weighted gradient-echo CMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial Infarct Size (Infarct %LV) | 48-72 hours post-primary PCI | Infarct size expressed as a percentage of total left ventricular myocardial mass, quantified by phase-sensitive inversion-recovery late gadolinium enhancement CMR. |
| Microvascular Obstruction (MVO %LV) | 48-72 hours post-primary PCI | 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORKeyur P Vora, MD MS FACC
Indiana University
PRINCIPAL_INVESTIGATORRohan Dharmakumar, PhD
Indiana University
Outcome results
None listed