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Completed

NCT Number: NCT07502521

Dexrazoxane to Protect Against Hemorrhagic STEMI

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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Key information

Conditions

Acute Myocardial Infarction (AMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Synergy Cardiovascular Research Center

Rajkot, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • Adult (18 - 79 years).
  • First STEMI (EMS/ER ECG ST-elevation) with primary PCI planned.
  • Consent pathway available: Patient consent, Legally Acceptable Representative (LAR)
  • CMR likely be feasible (no known MRI-unsafe implant or absolute MRI prohibition)

Exclusion criteria

-

  • History of PCI or CABG within 1 year
  • Known dialysis/ESRD
  • Known pre-existing LVEF <40% from recent records
  • Known pregnancy or breastfeeding (history or clearly documented)
  • Current anthracycline chemotherapy or active chest radiation (per patient/chart).
  • On iron chelation now or documented iron-storage disease (hemochromatosis/thalassemia).
  • Concurrent trials: investigational drug or device use within 90 days.
  • Any clinically significant condition identified that would preclude safe peri-procedural administration of Dexrazoxane or completion of core protocol procedures.

Treatment and study plan

Dexrazoxane

Drug

Intravenous infusion administered adjunctively to primary PCI

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.

Primary outcomes

  1. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 48-72 hours post-primary PCI

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

  2. Intramyocardial Haemorrhage Burden (IMH %LV)

    Time frame: 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 outcomes

  1. Myocardial Infarct Size (Infarct %LV)

    Time frame: 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.

  2. Microvascular Obstruction (MVO %LV)

    Time frame: 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.

Other outcomes

  1. Right Ventricular Ejection Fraction (RVEF)

    Time frame: 48-72 hours post-primary PCI

    Global right ventricular systolic function expressed as a percentage, derived from contiguous short-axis SSFP cine CMR.

  2. High-Sensitivity Cardiac Troponin-I (hs-cTnI)

    Time frame: -1 hour pre-PCI through 48 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.

  3. Incidence of Major Bleeding (BARC Criteria)

    Time frame: First dose through 30 days

    Bleeding complications assessed using Bleeding Academic Research Consortium (BARC) criteria types 1-5.

Sponsors and collaborators

Lead sponsor

Rohan Dharmakumar

Other

Registry information

Official study title

Dexrazoxane for the Reduction of Haemorrhagic Myocardial Infarction in STEMI: A Double-Blind, Placebo-Controlled, Sequential-Cohort Phase IIa Trial

Acronym: SHIELD-MI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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