XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Radiation exposure measurement
研究概览
简要总结
This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.
详细描述
Cardiovascular interventional procedures are currently conducted under the guidance of X-ray fluoroscopy. Magnetic resonance imaging (MRI) can provide increased soft tissue information about the cardiovascular system. By combining the familiar X-ray environment with superior magnetic resonance imaging, the investigator hopes to enhance and expand the capabilities of cardiac catheterization techniques.
The investigator will conduct cardiac catheterization procedures using XFM guidance in pediatric research patients who are undergoing medically necessary procedures. The investigator aims to decrease the exposure of these patients to the routine hazards of ionizing radiation and contrast exposure compared to the standard of care approach.
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
- •Children and adults of any age
- •Undergoing clinically-indicated cardiovascular catheterization
排除标准
- •Cardiovascular instability precluding baseline medially-necesary MRI
- •Women who are pregnant
- •Women who are nursing and who do not plan to discard breast milk for 24 hours
- •All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning
结局指标
主要结局
Radiation exposure measurement
时间窗: At the end of each catheterization procedure through study completion,up to 8 years.
Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center
次要结局
- Fluoroscopy time measurement(At the end of each catheterization procedure through study completion,up to 8 years.)
- Contrast volume measurement(At the end of each catheterization procedure through study completion, up to 8 years.)
- Procedure time measurement(At the end of each catheterization procedure through study completion,up to 8 years.)
研究者
Joshua Kanter
Joshua Kanter, MD
Children's National Research Institute