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Trial record 2 of 18 for:    cardiac catheterization | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Right Heart Catheterization Using Magnetic Resonance Imaging Fluoroscopy and Passive Guidewires

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ClinicalTrials.gov Identifier: NCT03152773
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Right heart catheterization tests heart pressures and flows. Magnetic resonance imaging (MRI) fluoroscopy shows pictures of the heart that doctors can watch while they work. Researchers want to test this procedure with a tool called a guidewire. This will help position the heart catheter into different heart chambers. Guidewires are usually considered unsafe during MRI because MRI can make them hot inside the body. Researchers have created special MRI settings that stop one guidewire from getting hot. Using this guidewire during MRI may make improve catheterization.

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 will 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.

For right 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 Device: MRI Right Heart guidewire catheterization Phase 1 Phase 2

Detailed 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 one specific commercial guidewire. In this protocol we will use this new lowenergy real-time MRI fluoroscopy technique to enable use of guidewires during otherwise standard MRI catheterization of the right side of the heart through veins.

If the initial phases of the protocol prove successful, in subsequent amendments we will use this technique to position catheters in the left ventricle through arteries.

If successful, 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 : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Right Heart Catheterization Using MRI Fluoroscopy and Passive Guidewires
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: 1
Open label
Device: MRI Right Heart guidewire catheterization
To conduct right heart guidewire catheterization using real-time MRI fluoroscopy in human research subjects already undergoing medically necessary 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.




Primary Outcome Measures :
  1. To test the safety of performing right heart catheterization with a Terumo Glidewire guided by low-SAR MRI fluoroscopy [ Time Frame: 2 hours ]
    acquisition of hemodynamic and saturation data from targeted chambers and vessels.


Secondary Outcome Measures :
  1. To test in vivo human conspicuity of the glidewire using off-resonance MR image reconstruction. [ Time Frame: 2 hours ]
    Conspicuity of Glidewires during MRI fluoroscopy catheterization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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 FOR ADULTS:

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.


Information from the National Library of Medicine

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


Contacts
Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov

Locations
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   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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     History of Changes
Other Study ID Numbers: 170095
17-H-0095
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
MRI Catheterization
Real-time MRI

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases