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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07163988

Acronym

TROP-UDMI-ID

Enrollment

312

Registered

2025-09-09

Start date

2023-01-10

Completion date

2025-09-30

Last updated

2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction (AMI)

Keywords

Hemorrhagic Myocardial Infarction, CCS-AMI Stages of Myocardial Infarction, High sensitivity Cardiac Troponin-I, Non-hemorrhagic Myocardial Infarction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
High-sensitivity Cardiac Troponin-I Thresholds	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	48 hours	Define time window for high-sensitivity cardiac troponin-I threshold for AMI Stages I-IV

Secondary

Measure	Time frame	Description
Adjusted Risk Ratio	48 hours	Adjusted Risk Ratio to explore parameters to predict AMI Stages I-IV

Countries

United States

Outcome results