Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
研究概览
简要总结
The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).
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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for scintigraphy to assess myocardial ischaemia
- •Ability to give informed written consent.
排除标准
- •Impaired capacity to consent
- •Pregnancy, or breastfeeding
- •Allergy to iv contrast
- •Renal failure
- •Severe Uncontrolled asthma
- •Claustrophobia
研究组 & 干预措施
Single arm
This is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard. All the patients will undergo the three imaging protocols.
干预措施: Rubidium-82 (Drug)
Single arm
This is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard. All the patients will undergo the three imaging protocols.
干预措施: Sestamibi. reconstitution with sodium pertechnetate (99mTc) (Drug)
结局指标
主要结局
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
时间窗: Up to 2 days
The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being \>70% stenosis, on coronary CT angiography).
次要结局
- Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.(Up to 2 days)
- Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.(Up to 2 days)
- Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.(Up to 2 days)
- Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.(Up to 2 days)