Dexrazoxane to Protect Against Hemorrhagic STEMI

Rohan Dharmakumar50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Myocardial Infarction (AMI)

Interventions

DexrazoxaneDRUG

Intravenous infusion administered adjunctively to primary PCI

Normal SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (1)

Synergy Cardiovascular Research Center

Rajkot, India

Outcomes

Primary Outcomes

Left Ventricular Ejection Fraction (LVEF)

Global left ventricular systolic function expressed as a percentage, quantified by steady-state free-precession cine CMR

Time frame: 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

Time frame: 48-72 hours post-primary PCI

Secondary Outcomes

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.

Time frame: 48-72 hours post-primary PCI

Microvascular Obstruction (MVO %LV)

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.

Time frame: 48-72 hours post-primary PCI

Data from ClinicalTrials.gov

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