Acute Myocardial InfarctionMIRON-TROPNCT05872308
Hemorrhagic Myocardial Infarction Detection by Post-reperfusion Troponin Kinetics
An observational study of Acute Myocardial Infarction, run by Rohan Dharmakumar at 2 sites in 2 countries.
Trial summary
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 227 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Jul 2022to 21 Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).
Who may be able to join
- Age ≥ 18 years
- Index STEMI
- Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
- Ability to provide informed consent for themselves
Who cannot join
- History of prior myocardial infarction,
- Cardiogenic shock,
- Patients who present with current cardiac arrest
- Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
- Presence of permanent atrial fibrillation,
- Unconscious patient,
- Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy),
- Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site
Synergy Cardiovascular Research Center, Synergy Superspecialty Hospital
Rajkot, Gujarat
About this study
Official title: Hemorrhagic Myocardial Infarction Detection With High-sensitivity Cardiac Troponin-I
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction
- Conditions
- Acute Myocardial Infarction
- Keywords
- STEMI, Troponin, Intramyocardial Hemorrhage, Cardiac MRI
- Medical subject headings
- ST Elevation Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Threshold
Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct
Measured: 48 hours
Secondary outcomes (6)
Peak levels of serum troponin-I
peak levels of serum troponin-I in hemorrhagic infarct vs non-hemorrhagic infarct
Measured: 48 hours
Area under the curve (AUC) for serum troponin-I
area under the curve post-MI for troponin-I
Measured: 48 hours
Hemorrhagic infarct size
as determined by cardiac MRI
Measured: 48 hours
Hemorrhagic infarct volume
as determined by cardiac MRI
Measured: 48 hours
Hemorrhagic infarct microvascular obstruction
as determined by cardiac MRI
Measured: 48 hours
Hemorrhagic infarct area at risk
as determined by cardiac MRI
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start8 Jul 2022
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 227 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 FACC, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872308
- Sponsor's protocol ID
- 13081
- Acronym
- MIRON-TROP
- Status last verified
- Sep 2025
- First submitted
- 14 May 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vora KP, Kalra A, Shah CD, Bhatt K, Kumar A, Pandya T, Poptani V, Chan SF, Singh D, Jambunathan N, Subramanian R, Youssef K, Kanakasabai S, Finney R, Desai A, Kreutz RP, Kovacs RJ, Raman SV, Bhatt DL, Dharmakumar R. In-Hospital Mortality in Hemorrhagic Myocardial Infarction. NEJM Evid. 2025 Sep;4(9):EVIDoa2400294. doi: 10.1056/EVIDoa2400294. Epub 2025 Aug 26.
PubMed 40858097
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhagic Myocardial Infarction Detection With High-sensitivity Cardiac Troponin-I
- ClinicalTrials.gov ID
- NCT05872308
- Acronym / sponsor ID
- MIRON-TROP / 13081
- Conditions
- Acute Myocardial Infarction
- Keywords
- STEMI, Troponin, Intramyocardial Hemorrhage, Cardiac MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Rohan DharmakumarUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 24 May 2023 (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.
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Index STEMI
- Coronary angiogram with PCI to occur irrespective of the onset of the symptoms.
- Ability to provide informed consent for themselves
Key exclusion criteria (8 listed)
- History of prior myocardial infarction,
- Cardiogenic shock,
- Patients who present with current cardiac arrest
- Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium),
- Presence of permanent atrial fibrillation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Threshold
Time frame: 48 hours
Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct
6 secondary outcomes
Peak levels of serum troponin-I
Time frame: 48 hours
Area under the curve (AUC) for serum troponin-I
Time frame: 48 hours
Hemorrhagic infarct size
Time frame: 48 hours
Hemorrhagic infarct volume
Time frame: 48 hours
Hemorrhagic infarct microvascular obstruction
Time frame: 48 hours
Hemorrhagic infarct area at risk
Time frame: 48 hours
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 8 Sep 2025.
- Derived from this study: PubMed 40858097Vora KP, Kalra A, Shah CD, Bhatt K, Kumar A, Pandya T, Poptani V, Chan SF, Singh D, Jambunathan N, Subramanian R, Youssef K, Kanakasabai S, Finney R, Desai A, Kreutz RP, Kovacs RJ, Raman SV, Bhatt DL, Dharmakumar R. In-Hospital Mortality in Hemorrhagic Myocardial Infarction. NEJM Evid. 2025 Sep;4(9):EVIDoa2400294. doi: 10.1056/EVIDoa2400294. Epub 2025 Aug 26.
- 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 FACC principal investigator
Faculty
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Rohan Dharmakumar at 2 sites in 2 countries.
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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Diagnostic Threshold (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872308, which also lists 1 linked publication.
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 8 Sep 2025.