Acute Myocardial Infarction (AMI)TROP-STAGES-MINCT07163988
Acute MI UDMI Staging Diagnosis by High-sensitivity Cardiac Troponin-I
An observational study of Acute Myocardial Infarction (AMI), run by Rohan Dharmakumar at 1 site in United States.
Trial summary
TROP-MI-STAGE is a multicenter retrospective diagnostic study designed to evaluate the role of high-sensitivity cardiac troponin I (hs-cTnI) in the diagnosis and clinical stage classification of acute myocardial infarction as defined by the stages of myocardial injury in CCS-AMI classification. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 30 Sep 2025
- How long will I take part?
- 1 Year
- 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 to 79 years
- 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 18-79 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
1 site in 1 country.
United States1 site
Medical Imaging Research Institute
Indianapolis, Indiana, 46202
About this study
Official title: High-Sensitivity Cardiac Troponin I as a Diagnostic Marker for AMI Clinical Stage Classification in Acute Myocardial Infarction: A Retrospective Multicenter Study
TROP-MI-STAGE is a multicenter retrospective diagnostic study designed to evaluate the role of high-sensitivity cardiac troponin I (hs-cTnI) in the diagnosis and clinical stage classification of acute myocardial infarction as defined by the stages of myocardial injury in CCS-AMI classification.
The study retrospectively analyzes biomarker data from patients diagnosed with AMI across multiple institutions, focusing on whether hs-cTnI levels-measured at specific time points-can reliably identify and stratify patients into AMI clinical stages (Stage 1 to Stage 4). It aims to correlate hs-cTnI kinetics and peak levels with clinical stage, presentation patterns, and outcomes.
This trial seeks to offer a biomarker-based alternative to imaging-heavy staging, potentially streamlining early diagnosis and therapeutic triage for AMI patients in varied clinical settings.
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Hemorrhagic Myocardial Infarction, CCS-AMI Stages of Myocardial Infarction, High sensitivity Cardiac Troponin-I, Non-hemorrhagic Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Index STEMI with Primary PCI with Stenting | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity Cardiac Troponin-I Thresholds
Levels of hs-cTn-I to differentiate AMI Stages I-IV (Classified by CMR)
Measured: 48 hours
Time window for high-sensitivity cardiac troponin-I thresholds
Define time window for high-sensitivity cardiac troponin-I threshold for AMI Stages I-IV
Measured: 48 hours
Secondary outcomes (1)
Adjusted Risk Ratio
Adjusted Risk Ratio to explore parameters to predict AMI Stages I-IV
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 posted9 Sep 2025
- Study start10 Jan 2023
- Primary completion31 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Rohan Dharmakumar
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor-investigator, Rohan Dharmakumar, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163988
- Sponsor's protocol ID
- 27356b
- Acronym
- TROP-STAGES-MI
- Status last verified
- Nov 2026
- First submitted
- 1 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 40858097Vora KP, Kumar A, Krishnam MS, Prato FS, Raman SV, Dharmakumar R. Microvascular Obstruction and Intramyocardial Hemorrhage in Reperfused Myocardial Infarctions: Pathophysiology and Clinical Insights From Imaging. JACC Cardiovasc Imaging. 2024 Jul;17(7):795-810. doi: 10.1016/j.jcmg.2024.02.003. Epub 2024 Apr 10.
PubMed 38613553Kumar A, Connelly K, Vora K, Bainey KR, Howarth A, Leipsic J, Betteridge-LeBlanc S, Prato FS, Leong-Poi H, Main A, Atoui R, Saw J, Larose E, Graham MM, Ruel M, Dharmakumar R. The Canadian Cardiovascular Society Classification of Acute Atherothrombotic Myocardial Infarction Based on Stages of Tissue Injury Severity: An Expert Consensus Statement. Can J Cardiol. 2024 Jan;40(1):1-14. doi: 10.1016/j.cjca.2023.09.020. Epub 2023 Oct 28.
PubMed 37906238
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Cardiac Troponin I as a Diagnostic Marker for AMI Clinical Stage Classification in Acute Myocardial Infarction: A Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07163988
- Acronym / sponsor ID
- TROP-STAGES-MI / 27356b
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Hemorrhagic Myocardial Infarction, CCS-AMI Stages of Myocardial Infarction, High sensitivity Cardiac Troponin-I, Non-hemorrhagic Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Rohan DharmakumarUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 Sep 2025 (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.
TROP-MI-STAGE is a multicenter retrospective diagnostic study designed to evaluate the role of high-sensitivity cardiac troponin I (hs-cTnI) in the diagnosis and clinical stage classification of acute myocardial infarction as defined by the stages of myocardial injury in CCS-AMI classification.
The study retrospectively analyzes biomarker data from patients diagnosed with AMI across multiple institutions, focusing on whether hs-cTnI levels-measured at specific time points-can reliably identify and stratify patients into AMI clinical stages (Stage 1 to Stage 4). It aims to correlate hs-cTnI kinetics and peak levels with clinical stage, presentation patterns, and outcomes.
This trial seeks to offer a biomarker-based alternative to imaging-heavy staging, potentially streamlining early diagnosis and therapeutic triage for AMI patients in varied clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Index STEMI with Primary PCI with Stenting | – | –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 qualify
- Ages
- 18 to 79 years
- 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 18-79 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
High-sensitivity Cardiac Troponin-I Thresholds
Time frame: 48 hours
Levels of hs-cTn-I to differentiate AMI Stages I-IV (Classified by CMR)
Time window for high-sensitivity cardiac troponin-I thresholds
Time frame: 48 hours
Define time window for high-sensitivity cardiac troponin-I threshold for AMI Stages I-IV
1 secondary outcome
Adjusted Risk Ratio
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 4 Nov 2026.
- Background: 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.
- Background: PubMed 38613553Vora KP, Kumar A, Krishnam MS, Prato FS, Raman SV, Dharmakumar R. Microvascular Obstruction and Intramyocardial Hemorrhage in Reperfused Myocardial Infarctions: Pathophysiology and Clinical Insights From Imaging. JACC Cardiovasc Imaging. 2024 Jul;17(7):795-810. doi: 10.1016/j.jcmg.2024.02.003. Epub 2024 Apr 10.
- Background: PubMed 37906238Kumar A, Connelly K, Vora K, Bainey KR, Howarth A, Leipsic J, Betteridge-LeBlanc S, Prato FS, Leong-Poi H, Main A, Atoui R, Saw J, Larose E, Graham MM, Ruel M, Dharmakumar R. The Canadian Cardiovascular Society Classification of Acute Atherothrombotic Myocardial Infarction Based on Stages of Tissue Injury Severity: An Expert Consensus Statement. Can J Cardiol. 2024 Jan;40(1):1-14. doi: 10.1016/j.cjca.2023.09.020. Epub 2023 Oct 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction (AMI), run by Rohan Dharmakumar at 1 site in United States.
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 4 Nov 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 United States. 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?
High-sensitivity Cardiac Troponin-I Thresholds (time frame: 48 hours). 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?
On the ClinicalTrials.gov record for NCT07163988, which also lists 3 linked publications.
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 4 Nov 2026.