Dexrazoxane to Protect Against Hemorrhagic STEMI (SHIELD-MI)

May 21, 2026 updated by: Rohan Dharmakumar

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This Phase lla randomized trial evaluates if 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

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Rajkot, India
        • Synergy Cardiovascular Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexrazoxane Infusion
Participants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI.
Drug: Dexrazoxane
Intravenous infusion administered adjunctively to primary PCI
Placebo Comparator: Placebo Infusion
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.
Drug: Normal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48-72 hours post-primary PCI
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
48-72 hours post-primary PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48-72 hours post-primary PCI
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.
48-72 hours post-primary PCI

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48-72 hours post-primary PCI
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.
-1 hour pre-PCI through 48 hours post-primary PCI
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.
First dose through 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rohan Dharmakumar

Investigators

  • Principal Investigator: Keyur P Vora, MD MS FACC, Indiana University
  • Principal Investigator: Rohan Dharmakumar, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2025

Primary Completion (Actual)

February 15, 2026

Study Completion (Actual)

March 16, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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