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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-H-0095

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Pregnant Women;
Children

Keywords

MRI Catheterization;
Real-time MRI

Recruitment Keyword(s)

None

Condition(s)

Pulmonary Artery Hypertension;
Congenital Heart Disease;
Structural Heart Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: MRI Heart guidewire catheterization

Supporting Site

National Heart, Lung, and Blood Institute

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.

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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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Robert J. Lederman, M.D.
National Heart, Lung and Blood Institute (NHLBI)
NIHBC 10 - CLINICAL CENTER BG RM 2C713
10 CENTER DR
BETHESDA MD 20892
(301) 402-6769
lederman@nih.gov

Annette Stine, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-1464
10 Center Drive
Bethesda, Maryland 20892
(301) 402-5558
stinea@nhlbi.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03152773

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