Acute MI Staging Diagnosis by High-sensitivity Cardiac Troponin-I

NCT07163988 | Completed

• 1 other identifier: 27356b
• Study Type: observational
• Target: 312
• Locations: 2 countries
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• High-sensitivity Cardiac Troponin-I Thresholds

  Levels of hs-cTn-I to differentiate AMI Stages I-IV (Classified by CMR)

  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

  48 hours

Secondary Outcomes (1)

• Adjusted Risk Ratio

  48 hours

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University School of Medicine: collaborator
• Synergy Cardiovascular Research Center: collaborator
• Indiana University: lead

Study Sites (2)

Medical Imaging Research Institute

Indianapolis, Indiana, 46202, United States

Location

Synergy Cardiovascular Research Center

Rajkot, Gujarat, India

Location

Related Publications (3)

• 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.

  PMID: 40858097 BACKGROUND

• Vora 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.

  PMID: 38613553 BACKGROUND

• Kumar 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.

  PMID: 37906238 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical CV Imaging & Trials, Medical Imaging Research Institute

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: January 10, 2023
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IN (1)