Feasibility of Detecting Myocardial Ischemia by First-pass Contrast MRI Using Regadenoson
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI.
研究概览
简要总结
This is a pilot study to determine whether the drug regadenoson can be used during magnetic resonance imaging to assess regions of poor blood flow to the heart.
The hypothesis of this study is that a single injection of regadenoson could be used instead of a standard adenosine infusion to produce coronary vasodilatation and demonstrate myocardial ischemia during first-pass perfusion cardiac MRI.
详细描述
This is a pilot study that proposes to assess the feasibility of using regadenoson (Lexiscan, Astellas), a recently FDA approved A2A receptor agonist, as the stress perfusion agent in cardiac MRI perfusion examinations. While regadenoson has been approved by the FDA, it has not been approved for the specific indications of use 1) during the simultaneous intravenous administration of a gadolinium-based contrast agent, or 2) during magnetic resonance imaging (MRI).
Because this agent can be given intravenously in a single 400 microgram bolus, rather than in an infusion, this agent may be easier to administer than adenosine during an MRI examination.
The objectives for this pilot study are: 1) To demonstrate the feasibility of using regadenoson during cardiac perfusion MRI to visualize known regions of myocardial ischemia as demonstrated on SPECT-MPI and 2) To describe a cardiac perfusion MRI protocol using regadenoson that would have the potential to be used clinically.
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
- Single (Outcomes Assessor)
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
- •reversible perfusion abnormalities on a clinically ordered rest/adenosine dual-isotope SPECT-MPI in at least 2 contiguous myocardial segments (per 17-segment model)
排除标准
- •myocardial infarction, myocardial revascularization procedure or progression in angina occuring after the SPECT-MPI examination
- •pregnancy
- •gadolinium-based MR contrast allergy
- •glomerular filtration rate (GFR) > 60 mL/min/1.73 m2
- •contraindications to MR imaging (pacemaker, brain aneurysm clips, schrapnel, etc.)
研究组 & 干预措施
Regadenoson CMR
Images in the cardiac short axis will be obtained using a gradient recalled echo sequence, TR 2.3 msec/TE 1.1 msec, 80*256 matrix, slice thickness 10 mm. Images will be obtained during power injection of 0.075 mmol/Kg of a conventional gadolinium based MR contrast agent at a rate of 5 mL/sec followed by a 15 mL saline flush into an antecubital vein. Perfusion imaging will be performed at stress and rest. Stress: Regadenoson 400 mcg will be administered IV bolus via an antecubital cannula. Immediately after injection, MR scanning will begin and contrast will be given. Rest: After 10 minutes, rest imaging will be performed identically, but without regadenoson injection. To identify late enhancement of myocardial tissue inversion recovery prepared images will be obtained.
干预措施: Regadenoson (Drug)
结局指标
主要结局
Feasibility of use of regadenoson during cardiac perfusion MRI to visualize regions of myocardial ischemia as demonstrated on SPECT-MPI.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Pamela Woodard, MD
M.D., FACR, FAHA, FCCP
Washington University School of Medicine