Radiation-Free Heart Catheterization Using MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Test the feasibility of navigating catheters into right heart structures using real-time MRI
研究概览
简要总结
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
详细描述
Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing a medically necessary cardiovascular catheterization
排除标准
- •Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
- •Women who are pregnant
- •Women who are nursing and who do not plan to discard breast milk for 24 hours
- •Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
- •Central nervous system aneurysm clips
- •Implanted neural stimulator
- •Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Implanted Insulin pump
- •Metal shrapnel or bullet
- •Exclusion criteria for Gadolinium (contrast agent)
- •Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area
结局指标
主要结局
Test the feasibility of navigating catheters into right heart structures using real-time MRI
时间窗: At the end of each catheterization procedure through study completion,up to 5 years.
Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation.
次要结局
- Measurement of radiation exposure(End of study, 5 years.)
- Number of participants whose MRI cardiac catheterization procedure was prematurely terminated(At the end of each catheterization procedure through study completion,up to 5 years)
研究者
Joshua Kanter
MD
Children's National Research Institute