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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rohan Dharmakumar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings