Acute Myocardial Infarction (AMI)Phase 2SHIELD-MINCT07502521
Dexrazoxane to Protect Against Hemorrhagic STEMI
A Phase 2 study testing Dexrazoxane and Normal Saline in people with Acute Myocardial Infarction (AMI), run by Rohan Dharmakumar at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Dexrazoxane and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 30 Aug 2025to 16 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Dexrazoxane, Normal Saline
- Keywords
- Hemorrhagic Myocardial Infarction, Primary Percutaneous Coronary Intervention, Cardiac Magnetic Resonance, Intramyocardial Hemorrhage, ST Elevation Myocardial Infarction, Acute Myocardial Infarction
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexrazoxane Infusion | Experimental | Participants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI. Receives: Drug: Dexrazoxane |
| Placebo Infusion | Placebo comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
Global left ventricular systolic function expressed as a percentage, quantified by steady-state free-precession cine CMR
Measured: 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
Measured: 48-72 hours post-primary PCI
Secondary outcomes (2)
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.
Measured: 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.
Measured: 48-72 hours post-primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Aug 2025
- Primary completion15 Feb 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohan Dharmakumar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rohan Dharmakumar, Indiana University
- Investigators
- Keyur P Vora, MD MS FACC, Principal investigator, Indiana UniversityRohan Dharmakumar, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502521
- Sponsor's protocol ID
- 27356
- Acronym
- SHIELD-MI
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexrazoxane for the Reduction of Haemorrhagic Myocardial Infarction in STEMI: A Double-Blind, Placebo-Controlled, Sequential-Cohort Phase IIa Trial
- ClinicalTrials.gov ID
- NCT07502521
- Acronym / sponsor ID
- SHIELD-MI / 27356
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Hemorrhagic Myocardial Infarction, Primary Percutaneous Coronary Intervention, Cardiac Magnetic Resonance, Intramyocardial Hemorrhage, ST Elevation Myocardial Infarction, Acute Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rohan DharmakumarUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexrazoxane Infusion | Experimental | Drug: DexrazoxaneParticipants receive an intravenous infusion of Dexrazoxane in the ER, followed by doses at 4, 8, and 12 hours post-primary PCI. |
| Placebo Infusion | Placebo comparator | Drug: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexrazoxaneIntravenous infusion administered adjunctively to primary PCI | Drug | Dexrazoxane Infusion |
| Normal SalineVisually 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. | Drug | Placebo Infusion |
Primary outcome
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
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
2 secondary outcomes
Myocardial Infarct Size (Infarct %LV)
Time frame: 48-72 hours post-primary PCI
Microvascular Obstruction (MVO %LV)
Time frame: 48-72 hours post-primary PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keyur P Vora, MD MS FACC principal investigator
Indiana University
Rohan Dharmakumar, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexrazoxane and Normal Saline in people with Acute Myocardial Infarction (AMI), run by Rohan Dharmakumar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (LVEF) (time frame: 48-72 hours post-primary PCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.