Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires
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| ClinicalTrials.gov Identifier: NCT03152773 |
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Recruitment Status :
Recruiting
First Posted : May 15, 2017
Last Update Posted : May 19, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Artery Hypertension Congenital Heart Disease Structural Heart Disease | Procedure: MRI Heart guidewire catheterization | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Heart Catheterization Using Magnetic Resonance Imaging (MRI) Fluoroscopy and Passive Guidewires |
| Actual Study Start Date : | August 2, 2017 |
| Estimated Primary Completion Date : | December 30, 2024 |
| Estimated Study Completion Date : | December 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
Open label
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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. |
- 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 [ Time Frame: 2 hours ]Acquisition of hemodynamic and saturation data from targeted chambers and vessels.
- Additional objectives are to test and enhanced MRI as an adjunct to routine hemodynamic cardiac catheterization [ Time Frame: 2 hours ]Conspicuity of Glidewires during MRI fluoroscopy catheterization
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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
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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
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): NCT03152773
| Contact: Annette Stine, R.N. | (301) 402-5558 | stinea@nhlbi.nih.gov | |
| Contact: Robert J Lederman, M.D. | (301) 402-6769 | lederman@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | 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 prpl@cc.nih.gov | |
| Principal Investigator: | Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT03152773 |
| Other Study ID Numbers: |
170095 17-H-0095 |
| First Posted: | May 15, 2017 Key Record Dates |
| Last Update Posted: | May 19, 2023 |
| Last Verified: | February 23, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | .The authors are willing to share de-identified subject data upon reasonable request |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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MRI Catheterization Real-time MRI |
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Pulmonary Arterial Hypertension Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities |
Congenital Abnormalities Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |