Study of Acute and Chronic Myocardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
研究概览
简要总结
The study is about exploring physiological angiogenesis linked to tissue repair in patients with acute heart infarction or chronic heart ischemia by means of 68Ga-NODAGA-RGD PET/CT imaging.
详细描述
Several animal studies have demonstrated the expression of αvβ3 integrins on the surface of the endothelium present in neovessels in formation, especially during neoangiogenesis after myocardial ischemic injury.
68Ga-NODAGA-RGD is a positron-emission-tomography (PET) ligand targeted towards αvβ3 integrins. αvβ3 integrins could potentially act as a biomarker for the follow-up of heart infarction.
In the present study, 68Ga-NODAGA-RGD PET/CT imaging is a tool to understand and evaluate tissue repair after heart lesion and its evolution allowing a better management of patients with occluded artery.
Three groups of patients are included : patients with acute infarction, patients with acute infarction requiring reperfusion treatment and patients with chronic ischemic occlusion.
Each patient would benefit from a 82Rb (82rubidium) PET/CT as part of standard management and from a 68Ga-NODAGA-RGD PET/CT as part of the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute infarction or patients with acute infarction requiring reperfusion treatment or patients with chronic ischemic occlusion
- •Karnofsky ≥ 80%
- •signed informed consent
排除标准
- •pregnancy, breastfeeding
- •claustrophobia
- •contra-indication to adenosine administration
- •lack of discernment to sign informed consent
结局指标
主要结局
82Rb PET/CT : assessment of change of myocardial blood flow reserve at rest and at stress
时间窗: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
82Rb PET/CT : assessment of change of myocardial blood flow at rest and at stress
时间窗: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
82Rb PET/CT : assessment of change of difference of myocardial blood flow at stress and at rest
时间窗: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
mL/min/g
68Ga-NODAGA PET/CT : assessment of change of standard uptake value (SUV)
时间窗: at 1, 4 and 12 weeks post ischemic events for patients of groups 1 and 2 - Before and 2 months after reperfusion treatment for patients of group 3
g/ml
次要结局
未报告次要终点
研究者
John O. Prior
PhD, MD, Head of Nuclear Medicine Department
University of Lausanne Hospitals