Real-time MRI Right Heart Catheterization Using Passive Catheters
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01287026|
Recruitment Status : Recruiting
First Posted : February 1, 2011
Last Update Posted : May 17, 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287026
|Contact: Annette Stine, R.N.||(301) email@example.com|
|Contact: Robert J Lederman, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Robert J Lederman, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|