STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Precent Akinesia
研究概览
简要总结
The aim of this study is to examine in-depth cardiac function and morphology after short-term coronary occlusion by balloon inflation in patients with stable coronary artery disease (CAD) who undergo percutaneous coronary intervention (PCI).
详细描述
Primary objectives:
- To determine the time-course for the resolution of regional myocardial function after short-term coronary artery occlusion in patients with stable CAD who undergo PCI.
Secondary objectives: 2. To confirm by cardiac magnetic resonance imaging that no myocardial injury occurs after short-term coronary occlusion in patients who undergo PCI due to stable CAD. 3. To establish a clinical model for studying myocardial stunning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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.
- •Stable CAD with indication for PCI of a lesion in either of the following coronary segments:
- •6 or 7 (proximal or mid left anterior descending coronary artery)
- •11 (Proximal left circumflex coronary artery)
- •1 or 2 (proximal right coronary artery)
- •Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography.
- •Written informed consent obtained.
排除标准
- •Pre-existing heart failure
- •Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel.
- •Severe valvulopathy
- •Thrombolysis In Myocardial Infarction (TIMI) flow <3 in the target vessel.
研究组 & 干预措施
Patients with a significant coronary artery lesion
Balloon inflation for 90s
干预措施: Intracoronary balloon inflation (Other)
结局指标
主要结局
Precent Akinesia
时间窗: 30 minutes post balloon occlusion
Time until recovery of percent akinesia (percent Akinesia; defined as more than 80 percent recovery compared to percent Akinesia at 30 minutes post balloon occlusion).
次要结局
- Difference in radial myocardial Strain(30 minutes)
- Time until recovery of radial Strain(30 minutes)
- Radial myocardial Strain(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)
- Global longitudinal Strain(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)
- Percent Akinesia(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)
- Myocardial wall motion index(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)
- Left ventricular stroke volume index(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)
- Difference in percent Akinesia(30 minutes)
- Left ventricular ejection fraction(1, 10, 30, 60, 120, 180 and 300 minutes and 24, 48 and 72 hours)