NCT05872308已完成不适用
Hemorrhagic Myocardial Infarction Detection With High-sensitivity Cardiac Troponin-I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- Diagnostic Threshold
研究概览
简要总结
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 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.
结局指标
主要结局
Diagnostic Threshold
时间窗: 48 hours
Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct
次要结局
- Peak levels of serum troponin-I(48 hours)
- Hemorrhagic infarct microvascular obstruction(48 hours)
- Area under the curve (AUC) for serum troponin-I(48 hours)
- Hemorrhagic infarct volume(48 hours)
- Hemorrhagic infarct area at risk(48 hours)
- Hemorrhagic infarct size(48 hours)
研究者
Rohan Dharmakumar
Vice Chair of Research, Medical Imaging Research Institute
Indiana University School of Medicine
研究点 (2)
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