CCS-AMI Staging Diagnosis by High-sensitivity Cardiac Troponin-I (MIRON CCS-AMI)

Indiana University

Status: Completed

Conditions: Acute Myocardial Infarction (AMI)

Study type: Observational

Funder types: Other

Identifiers

NCT07163988

27356b

Details and patient eligibility

About

MIRON-CCS 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 (AMI) as defined by the Canadian Cardiovascular Society (CCS) AMI staging system.

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 CCS-defined 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.

Enrollment: 312 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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.

Trial design

312 participants in 1 patient group

Index STEMI with Primary PCI with Stenting

Description:

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).