Real-time MRI Right Heart Catheterization Using Passive Catheters
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|ClinicalTrials.gov Identifier: NCT01287026|
Recruitment Status : Recruiting
First Posted : February 1, 2011
Last Update Posted : March 29, 2018
- 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.
- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters.
- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Caridovascular Disease Congenital Heart Disease Pulmonary Hypertension||Device: Balloon catheter for right heart catheterization Drug: Gadopentate Dimeglumine (Gadolinium); Contrast Agent Procedure: Right Heart Catheterization Procedure: Cardiac Real-time MRI Procedure: Vascular Hemostasis||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Real-Time MRI Right Heart Catheterization Using Passive Catheters|
|Study Start Date :||January 25, 2011|
|Estimated Primary Completion Date :||December 28, 2018|
|Estimated Study Completion Date :||December 28, 2018|
- To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI-guidance and "passive" catheters
- To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures
- To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287026
|Contact: Annette Stine, R.N.||(301) firstname.lastname@example.org|
|Contact: Robert J Lederman, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|