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

Rohan Dharmakumar312 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

312

Conditions

Acute Myocardial Infarction (AMI)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

High-sensitivity Cardiac Troponin-I Thresholds

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

Time frame: 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

Time frame: 48 hours

Secondary Outcomes

Adjusted Risk Ratio

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

Time frame: 48 hours

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes