CompletedNot Applicable

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

United States, India312 participantsStarted 2023-01-10

Plain-language 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.

Who can participate

Age range18 Years – 79 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

High-sensitivity Cardiac Troponin-I Thresholds

Timeframe: 48 hours

Time window for high-sensitivity cardiac troponin-I thresholds

Timeframe: 48 hours

Trial details

NCT IDNCT07163988

SponsorIndiana University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-31