Ischemic Time and Extent of Myocardial Infarction With Cardiac Magnetic Resonance Image in Patients With STEMI and Primary Percutaneous Coronary Intervention Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CMRI myocardial infarct size
研究概览
简要总结
This study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation myocardial infarction) and primary percutaneous coronary intervention.
详细描述
Background:
Cardiac magnetic resonance image (CMRI) is the preferred method of assessing myocardial infarct size and function. However,the relationship between CMRI changes and the ischemic time [symptom onset to device activation time (S2D)] in patients with primary percutaneous coronary intervention (PCI) is not well understood.
Hypothesis:
The investigators will test the primary hypothesis that there is strong (at least 70%) direct correlation between the S2D time and infarct size by CMRI and inverse correlation with myocardial salvage.
Method:
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
- •Clinical features, EKG, cTn elevation, and coronary catheterization findings consistent with an acute STEMI and having primary PCI, with age greater than 18 years, and GFR >= 60 mL/min/1.73m2.
排除标准
- •Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
- •Pregnancy or breast-feeding
- •Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
- •Body weight > 400lb
- •Unwilling to participate in the research protocol
- •History of allergic reactions to gadlinium based contrast agents.
- •Too critically ill to receive a MRI
结局指标
主要结局
CMRI myocardial infarct size
时间窗: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
The primary outcome measure is the CMRI myocardial infarct size (scar).
次要结局
- CMRI transmurality of scar(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.)
- CMRI area at risk(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.)
- CMRI myocardial salvage index(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.)
- CMRI microvascular obstruction (MVO)(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months)
- CMRI left ventricle (LV) thrombus(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.)
- CMRI LV ejection fraction (EF)(Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.)