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NCT Number: NCT07163988

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

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.

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Key information

Conditions

Acute Myocardial Infarction (AMI)

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Imaging Research Institute

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. High-sensitivity Cardiac Troponin-I Thresholds

    Time frame: 48 hours

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

  2. 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

Secondary outcomes

  1. Adjusted Risk Ratio

    Time frame: 48 hours

    Adjusted Risk Ratio to explore parameters to predict AMI Stages I-IV

Sponsors and collaborators

Lead sponsor

Rohan Dharmakumar

Other

Collaborators

  • Indiana University

Registry information

Official study title

High-Sensitivity Cardiac Troponin I as a Diagnostic Marker for AMI Clinical Stage Classification in Acute Myocardial Infarction: A Retrospective Multicenter Study

Acronym: TROP-MI-STAGE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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