High-Sensitivity Cardiac Troponin I as a Diagnostic Marker for AMI Clinical Stage Classification in Acute Myocardial Infarction: A Retrospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- High-sensitivity Cardiac Troponin-I Thresholds
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Index STEMI with Primary PCI with Stenting
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).
结局指标
主要结局
High-sensitivity Cardiac Troponin-I Thresholds
时间窗: 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
时间窗: 48 hours
Define time window for high-sensitivity cardiac troponin-I threshold for AMI Stages I-IV
次要结局
- Adjusted Risk Ratio(48 hours)
研究者
Rohan Dharmakumar
Executive Director, Medical Imaging Research Institute
Indiana University