Real-Time MRI Right Heart Catheterization Using Passive Catheters
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and
研究概览
简要总结
Background:
- Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization.
Objectives:
- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters.
Eligibility:
- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure.
Design:
- The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization.
- Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.
详细描述
Heart catheterization is a minimally invasive procedure to measure pressure and inject dye into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure and which fails to visualize soft tissue.
We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. In the first phase of this protocol we showed that comprehensive right-sided heart catheterization is feasible in adult patients, using commercially available MRI-compatible ( passive ) catheters.
In the second phase of the protocol, we began performing systematic right-sided heart catheterization without X-ray whenever possible. We will assess the hearts response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique
If successful, this will enable future testing of devices for adult and pediatric MRI-guided catheterization, such as special active wire guides, which may lead to new non-surgical treatments of cardiovascular disease.
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
- 2 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Open Label
干预措施: Cardiac Real-time MRI RHC (Right Heart Catheterization) (Procedure)
结局指标
主要结局
To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and
时间窗: Ongoing
There will be no heating or adverse events related to the MRI RHC.
次要结局
- To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures(Ongoing)
- To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans(Ongoing)