A Phase I Open Label Pilot Study to Evaluate the Safety, Efficacy and Tolerability of Anginera for Adults With Left Ventricular Dysfunction AND Reversible Myocardial Ischemia Undergoing CABG Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Physical exam and interval medical history
研究概览
简要总结
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
详细描述
A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted.
The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been referred for CABG
- •Left ventricular ejection fraction (LVEF) greater than 20%
- •Patients have CAD involving at least two (2) coronary arteries, with at least one or more vessel(s) having disease not amenable to bypass grafting or PCI
- •There is a region of myocardium served by the vessel(s) defined above that has objective evidence of multi-distribution reversible ischemia based on a 17-segment assessment of reversible defects on SPECT/Thallium.
排除标准
- •Subjects meeting any of the following criteria will be excluded from the study:
- •Patient undergoing valve replacement or valve modification
- •Patient with significant or malignant ventricular arrhythmias, defined as a patient being treated for ventricular tachycardia and/or ventricular fibrillation with an implantable cardioverter/defibrillator (ICD) or a patient being treated with Amiodarone for these same tachyarrhythmias. (Note: having an implantable cardioverter/defibrillator (ICD) per se, in a patient who does not have significant or malignant ventricular arrhythmias, does not exclude the patient from this study.)
- •Patient requires urgent coronary artery bypass surgery
结局指标
主要结局
Physical exam and interval medical history
CBC and differential
Serum cardiac markers-Troponin I
Serum chemistries and urinalysis
Resting electrocardiogram (ECG)
24 hour Holter monitor
Adverse Events reporting
次要结局
未报告次要终点