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Real-time MRI Right Heart Catheterization Using Passive Catheters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287026
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description
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Brief Summary:

Background:

- Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization.

Objectives:

- To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters.

Eligibility:

- Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure.

Design:

  • The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization.
  • Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.

Condition or disease Intervention/treatment Phase
Caridovascular Disease Congenital Heart Disease Pulmonary Hypertension Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization) Phase 1 Phase 2

Detailed Description:

Heart catheterization is a minimally invasive procedure to measure pressure and inject dye into specific heart cavities. Heart catheterization usually uses X-ray guidance, which involves radiation exposure and which fails to visualize soft tissue.

We have developed real-time magnetic resonance imaging (MRI) to guide heart catheterization with tissue visualization but without X-ray radiation. In the first phase of this protocol we showed that comprehensive right-sided heart catheterization is feasible in adult patients, using commercially available MRI-compatible ( passive ) catheters.

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

If successful, this will enable future testing of devices for adult and pediatric MRI-guided catheterization, such as special active wire guides, which may lead to new non-surgical treatments of cardiovascular disease.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Real-Time MRI Right Heart Catheterization Using Passive Catheters
Study Start Date : February 23, 2011
Actual Primary Completion Date : March 21, 2019
Actual Study Completion Date : March 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Open Label
 Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)


Outcome Measures
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Primary Outcome Measures :
  1. To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and [ Time Frame: Ongoing ]
    There will be no heating or adverse events related to the MRI RHC.


Secondary Outcome Measures :
  1. To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures [ Time Frame: Ongoing ]
  2. To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans [ Time Frame: Ongoing ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age greater than or equal to 2 years old

Undergoing medically necessary diagnostic or interventional right and/or 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:

  • Cardiac pacemaker or implantable defibrillator
  • 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/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria

Glomerular filtration rate will be estimated using the CKD-EPI equation (33):

eGFR equal 141 x (minimum of (Scr/K, 1)(a) x (maximum of (Scr/K, 1)) (-1.209) x 0.993(Ag x 1.018 (if female) x 1.159 (if black)

Where<TAB>Scr equal serum creatinine

a = -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 GADOLINIUM-BASED CONTRAST AGENTS FOR CHILDREN

Renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m(2) body surface area according to the Schwartz equation for estimation of GFR in children as recommended by the National Kidney Disease Education Program. The Schwartz equation is commonly used for GFR determination in children at Children s National Medical Center, Washington, DC.

GFR (mL/min/1.73 m2) = (k (SqrRoot) height) / serum creatinine concentration where K = constant defined as

follows:

k = 0.33 in premature infants [Excluded from this protocol]

k = 0.45 in term infants to 1 year of age [Excluded from this protocol]

k = 0.55 in children to 13 years of age

k = 0.70 in adolescent males (not females because of the presumed increase in male muscle mass,

the constant remains 0.55 for females)

  • Height in cm
  • Serum creatinine in mg/dL
Contacts and Locations
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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): NCT01287026


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01287026    
Other Study ID Numbers: 110091
11-H-0091
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 21, 2019

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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
Right Heart Catheterization
Pulmonary Artery Catheterization
MRI Safety
 Jugular Vein Catheterization
Heart Catheterization
Heart Disease
Cardiovascular Disease
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Heart Diseases
Heart Defects, Congenital
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities