Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

Congenital Heart Disease Clinical Trial

Official title:

Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03152773
• Other study ID #: 170095
• Secondary ID: 17-H-0095
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: December 30, 2025

Study information

• Verified date: February 13, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Annette Stine, R.N.
• Phone: (301) 402-5558
• Email: stinea[@]nhlbi.nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Heart catheterization is a minimally invasive procedure to measure pressure into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure, and which fails to visualize soft tissue. For several years, real-time magnetic resonance imaging (MRI) fluoroscopy has been the standard technique to guide right heart catheterization at the NIH clinical center.

Guidewires are standard tools used to steer catheters through the body and heart. Guidewires have not been used during MRI fluoroscopy catheterization because of the risk of heating. We have developed MRI techniques that do not risk heating using specific commercial guidewires. In this protocol we will use this new low-energy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins, and of the left side of the heart through the aorta.

In the second phase of the protocol, we will begin performing systematic MRI guidewire heart catheterization without X-ray whenever possible. We will assess the heart s response to hemodynamic provocation during MRI catheterization tailored to the patient s problem. We will use this protocol to further refine the technique.

This will enable future testing of devices for adult and pediatric MRI-fluoroscopy catheterization, which may lead to new non-surgical treatments of cardiovascular disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

• Age greater than or equal to 18 years old

• Undergoing medically necessary diagnostic or interventional right cardiovascular catheterization, alone or in combination with a left cardiovascular catheterization

EXCLUSION CRITERIA:

• Cardiovascular instability including ongoing acute myocardial infarction, refractory angina or ischemia, and decompensated congestive heart failure.

• Women who are pregnant or nursing

• Unable to undergo magnetic resonance imaging

• Cerebral aneurysm clip

• Neural stimulator (e.g. TENS-Unit)

• Any type of ear implant

• Ocular foreign body (e.g. metal shavings)

• Metal shrapnel or bullet.

• Any implanted device (e.g. insulin pump, drug infusion device), unless it is labeled safe for MRI

EXCLUSION CRITERIA FOR GADOLINIUM-BASED CONTRAST AGENTS:

Renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria

Glomerular filtration rate will be estimated using the CKD-EPI equation:

eGFR = 141 x (minimum of (S(Cr)/k, 1)^alpha x (maximum of (S(Cr) /k, 1))^-1.209 x 0.993^Age x 1.018 (if female) x 1.159 (if black)

Where

S(Cr) = serum creatinine

alpha = -0.329 for females and -0.411 for males

k = 0.7 for females and 0.9 for males

Subjects meeting this exclusion criterion may still be included in the study but may not be exposed to gadolinium-based contrast agents.

Exclusion criteria for ferumoxytol:

• Allergy to ferumoxytol or to mannitol excipient

• Does not wish to be exposed to ferumoxytol

Exclusion criteria for MRI left heart catheterization:

-Severe aortic valve stenosis

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Arterial Hypertension
• Pulmonary Artery Hypertension
• Structural Heart Disease

Intervention

Procedure:
• MRI Heart guidewire catheterization
to conduct left and right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary left and right heart catheterization. We will use only passive MRI-compatible catheters and a specific guidewire shown to be safe under specific conditions. Under the conditions of use, the guidewire is not susceptible to heating.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The principal objective of this protocol is to test the safety and feasibility of MRI fluoroscopy catheter navigation using 0.035 guidewires during left and right heart catheterization guided by low-SAR MRI pulse sequences	Acquisition of hemodynamic and saturation data from targeted chambers and vessels.	2 hours
Secondary	Additional objectives are to test and enhanced MRI as an adjunct to routine hemodynamic cardiac catheterization	Conspicuity of Glidewires during MRI fluoroscopy catheterization	2 hours

External Links

•   NIH Clinical Center Detailed Web Page