NCT01287910终止不适用
Effect of Transmyocardial Laser Revascularization on Myocardial Perfusion and Left Ventricular Structure by Cardiovascular Magnetic Resonance Imaging and Dynamic Volumetric Computed Tomography
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
研究概览
简要总结
The primary goal of this study is to better understand how Transmyocardial Laser Revascularization (TMR) affects the functioning of the heart and, in turn, relieves angina in individuals with coronary heart disease using Magnetic Resonance (MR) images and Computed Tomography (CT) images in some patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female 18 years of age or over
- •Patients with medically refractory, severe, class III or IV angina based on the Canadian Cardiovascular Society angina scale as determined by a physician
- •Ejection fraction 25% or greater
- •Patients with significant ischemia in the myocardium and who are NOT candidates for treatment by direct coronary revascularization methods (i.e., CABG or PCI)
- •Ability and willingness to consent and Authorization for use of PHI
排除标准
- •Patient cannot undergo a surgical procedure or general anesthesia
- •Patient not eligible for CMR study
- •Severe unstable angina
- •Q-wave MI within 3 weeks prior to TMR
- •NQWMI within 2 weeks prior to TMR
- •Decompensated heart failure (class III/IV) at the time of procedure
- •Known increased bleeding risk
- •Implanted pacemaker or defibrillator
- •Clinically unstable arrhythmia
- •Not able or willing to adhere to the study tests and procedures
- •Inability or unwillingness to consent and Authorization for use of PHI
结局指标
主要结局
Number of coronary arteries with blood flow defects evaluated by magnetic resonance imaging (MRI) or computed tomography (CT)
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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