Effect of O2 Tension on Myocardial Injury During TAVI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Troponin I
研究概览
简要总结
Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.
详细描述
Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for transcatheter aortic valve replacement due to aortic stenosis
排除标准
- •Transapical approach
- •Pre-procedural PaO2 < 65 mmHg or oxygen support therapy
- •Pre-procedural severe kidney injury (end-stage renal disease)
- •Pre-procedural chronic pulmonary disease, symptomatic asthma
- •Pre-procedural Tb-destroyed lung
- •Lung cancer
- •History of acute coronary syndrome within 6 months
- •Pre-procedural elevated Troponin I or CKMB
- •History of stroke or transient ischemic attack within 6 months
- •Refuse to participate
结局指标
主要结局
Troponin I
时间窗: 72 hours after the end of procedure
Area under the curve of troponin I
次要结局
- CK MB(72 hours after the end of procedure)
- Delirum(through admission completion, an average of 5 days)
- stroke, myocardial infarction or mortality(through admission completion, an average of 5 days)
- AKI or RRT(through admission completion, an average of 5 days)
- Changes in cerebral oximetry(through procedure completion, an average of 3 hours)
研究者
Yunseok Jeon
Prinicipal investigator
Seoul National University Hospital