MRI-Guided Catheterization for Heart Disease

Overseen By Robert J Lederman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Cardiovascular instability, Pregnancy, MRI incompatibility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

22 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: A heart catheterization is a diagnostic heart procedure used to measure pressures and take pictures of the blood flow through the heart chambers. Magnetic resonance imaging (MRI) fluoroscopy shows continuous pictures of the heart chambers that doctors can watch while they work. Researchers want to test this procedure with catheterization tools routinely used in x-ray catheterization called guidewires. Guidewires will help move the heart catheter through the different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can cause a guidewire to heat while inside the blood vessels and heart. Researchers are testing special low energy MRI settings that allow certain guidewires to be used during MRI catheterization without heating. Using these guidewires during MRI may help to decrease the amount of time you are in the MRI scanner, and the overall time the MRI catheterization procedure takes. Objectives: To test if certain MRI settings make it safe to use a guidewire during MRI fluoroscopy. Eligibility: Adults 18 and older whose doctors have recommended right heart catheterization. Design: Researchers will screen participants by reviewing their lab results and questionnaire answers. Participants may give 4 blood samples. Participants will be sedated. They will have a tube (catheter) placed in the groin, arm, or neck if they don t already have one. Patches on the skin will monitor heart rhythm. Special antennas, covered in pads, will be placed against the body. Participants will lie flat on a table that slides in and out of the MRI scanner as it makes pictures. Participants will get earplugs for the loud knocking noise. They can talk on an intercom. They will be inside the scanner for up to 2 hours. They can ask to stop at any time. During a heart catheterization, catheters will be inserted through the tubes already in place. The catheters are guided by MRI fluoroscopy into the chambers of the heart and vessels. The guidewire will help position the catheter.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

What data supports the idea that MRI-Guided Catheterization for Heart Disease is an effective treatment?

The available research shows that MRI-Guided Catheterization for Heart Disease is effective because it offers better visualization of soft tissues and heart structures without exposing patients to harmful radiation, unlike traditional x-ray methods. This is especially important for children who may need repeated procedures. MRI guidance allows for detailed three-dimensional images, which help doctors see the heart and blood vessels more clearly. Studies have shown that MRI-guided procedures can be performed successfully in both animals and humans, indicating its potential as a safe and effective treatment option. ^{1 2 3 4 5}

What safety data exists for MRI-guided catheterization for heart disease?

Safety data for MRI-guided catheterization primarily comes from preclinical studies and initial human trials. Preclinical studies in swine models have demonstrated the feasibility and safety of using MRI-compatible devices, such as guidewires and catheters, for cardiac interventions. These studies have shown that MRI-guided procedures can be performed without ionizing radiation, offering superior tissue imaging. Initial human trials have been conducted, but widespread clinical application has been limited by the availability of MRI-compatible equipment. Recent advancements in guidewire and catheter technology have improved safety and visualization, paving the way for future clinical use. ^{1 6 7 8 9}

Is MRI-guided heart catheterization a promising treatment for heart disease?

Yes, MRI-guided heart catheterization is a promising treatment for heart disease. It offers better visualization of soft tissues and heart structures without using harmful radiation, unlike traditional methods. This technique allows doctors to see the heart in three dimensions and assess both its structure and function in real-time. It has shown potential in both animal and early human studies, and ongoing improvements in technology are making it more effective and accessible. ^{1 3 4 5 10}

Research Team

Robert J Lederman, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

This trial is for adults over 18 who need a heart catheterization, which is a procedure to check heart function. Participants must not be pregnant or nursing, have severe heart valve issues, unstable heart conditions like ongoing attacks or failure, and can't have certain metal implants or allergies to MRI contrast agents.

Inclusion Criteria

I am scheduled for a heart catheterization procedure.

Exclusion Criteria

I have a severe narrowing of my heart's aortic valve.

I am not pregnant or nursing.

You cannot have a magnetic resonance imaging (MRI) scan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo MRI fluoroscopy catheterization using guidewires to measure heart pressures and visualize heart chambers.

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure.

1-2 weeks

Treatment Details

Interventions

• MRI Heart guidewire catheterization
• MRI Right and Left Heart guidewire catheterization

Trial Overview The study tests if using special guidewires during an MRI-guided heart catheterization is safe with low energy settings that prevent the wires from heating up. This could make the procedure quicker and reduce time in the MRI machine.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

Open label

MRI Heart guidewire catheterization is already approved in United States, European Union for the following indications:

Approved in United States as MRI-guided heart catheterization for:

• Diagnostic heart procedure for measuring pressures and imaging blood flow through heart chambers

Approved in European Union as MRI-guided heart catheterization for:

• Diagnostic heart procedure for measuring pressures and imaging blood flow through heart chambers

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Findings from Research

MRI-guided cardiac catheterization offers a safer alternative to traditional x-ray methods by reducing radiation exposure, particularly important for children who are more vulnerable to cumulative radiation effects.

Recent advancements in MRI technology, including improved catheter tracking and the development of MRI-compatible guidewires, have enhanced the feasibility and effectiveness of MRI-guided interventions, paving the way for broader clinical applications in diagnosing and treating congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-guided Cardiac Interventions. Pushparajah, K., Chubb, H., Razavi, R.[2019]

A new clinical-grade MRI guidewire with an internal fiberoptic temperature probe allows for real-time monitoring of temperature during catheterization, enhancing safety by detecting potential overheating without affecting the guidewire's flexibility or visibility.

In tests, the guidewire showed negligible heating under normal MRI operating conditions, with only a slight temperature increase observed during high RF power mode, indicating it can be safely used in interventional cardiovascular procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI active guidewire with an embedded temperature probe and providing a distinct tip signal to enhance clinical safety. Sonmez, M., Saikus, CE., Bell, JA., et al.[2021]

MRI guidance for coronary interventions offers significant advantages over traditional x-ray angiography, including the use of nonionizing radiation and the ability to assess both anatomy and function of the coronary arteries in three dimensions.

Recent studies have demonstrated the feasibility of real-time coronary MR angiography with high spatial and temporal resolution, suggesting that MRI could become a valuable tool for diagnosing and treating coronary artery disease in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided coronary interventions. Tsekos, NV., Atalar, E., Li, D., et al.[2007]

MRI-guided cardiac catheterisation is a safe and practical alternative to traditional fluoroscopic methods, allowing for better visualization of soft tissues and lower radiation exposure for patients.

In a study of 16 cases, MRI guidance provided valuable physiological information and improved the planning and execution of procedures like balloon angioplasty and radiofrequency ablation, suggesting it could become the preferred method for treating congenital heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac catheterisation guided by MRI in children and adults with congenital heart disease. Razavi, R., Hill, DL., Keevil, SF., et al.[2022]

This study tested the use of magnetic resonance imaging (MRI) for real-time visualization during coronary catheterization, using loopless antennas as guidewires and guiding catheters in six healthy dogs.

The results showed that MRI could successfully provide simultaneous images of the guidewire, guiding catheter, and chest anatomy, indicating a promising step towards safer and more effective MRI-guided coronary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward MRI-guided coronary catheterization: visualization of guiding catheters, guidewires, and anatomy in real time. Serfaty, JM., Yang, X., Aksit, P., et al.[2019]

A new MR-compatible guide wire was successfully used in a preclinical study involving 20 cardiac interventions in swine, demonstrating its safety and efficacy for procedures like balloon dilation of heart valves.

The first two human cases using this MR-guided technique were successful in relieving valvar pulmonary stenosis in both a child and an adult, with no complications reported, suggesting a promising future for MR-guided cardiac interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided cardiac interventions using magnetic resonance-compatible devices: a preclinical study and first-in-man congenital interventions. Tzifa, A., Krombach, GA., Krämer, N., et al.[2012]

In a preclinical study involving 13 pigs, real-time MRI (rtMRI) successfully guided stenting procedures for aortic coarctation, demonstrating its safety and feasibility using commercially available catheter devices.

The use of 'active' guidewires with MRI antennas significantly improved device visualization and reduced procedure time compared to standard guidewires, while rtMRI allowed for immediate identification of complications like aortic rupture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance imaging-guided stenting of aortic coarctation with commercially available catheter devices in Swine. Raval, AN., Telep, JD., Guttman, MA., et al.[2021]

The novel MRI-visible glass-fiber epoxy-based guidewire demonstrated excellent safety during 3T MRI procedures, with guidewire tip heating not exceeding 0.35°C, indicating minimal risk of thermal injury.

Real-time MRI-guided cardiovascular catheterization was successfully performed in both healthy and infarcted porcine models, with an average procedure time of 4:32, showcasing the guidewire's effective visualization and navigation capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time 3T MRI-guided cardiovascular catheterization in a porcine model using a glass-fiber epoxy-based guidewire. Li, X., Perotti, LE., Martinez, JA., et al.[2020]

Three main strategies for visualizing MR-dedicated guidewires and catheters have been identified: active tracking, locally induced field inhomogeneity, and passive susceptibility-based tracking, each with its own advantages and disadvantages.

The article discusses the development of these MR tracking techniques, including scan methods and post-processing tools, highlighting their potential to improve the accuracy and effectiveness of medical procedures involving guidewires and catheters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventional MR: vascular applications. Smits, HF., Bos, C., van der Weide, R., et al.[2020]

MRI catheterization is a new, radiation-free procedure that allows for simultaneous invasive hemodynamic assessment and MRI functional imaging, improving the diagnosis and management of complex cardiopulmonary diseases.

This innovative technique is already being used in specialized centers in the U.S. and Europe, and advancements in medical device design are expected to expand its applications to interventional procedures in the near future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI catheterization in cardiopulmonary disease. Rogers, T., Ratnayaka, K., Lederman, RJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

MR-guided Cardiac Interventions. [2019]

2. England pubmed.ncbi.nlm.nih.gov

MRI active guidewire with an embedded temperature probe and providing a distinct tip signal to enhance clinical safety. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging-guided coronary interventions. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Cardiac catheterisation guided by MRI in children and adults with congenital heart disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Toward MRI-guided coronary catheterization: visualization of guiding catheters, guidewires, and anatomy in real time. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided cardiac interventions using magnetic resonance-compatible devices: a preclinical study and first-in-man congenital interventions. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance imaging-guided stenting of aortic coarctation with commercially available catheter devices in Swine. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Real-time 3T MRI-guided cardiovascular catheterization in a porcine model using a glass-fiber epoxy-based guidewire. [2020]

9. Germany pubmed.ncbi.nlm.nih.gov

Interventional MR: vascular applications. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

MRI catheterization in cardiopulmonary disease. [2021]