Real-time MRI Right Heart Catheterization Using Passive Catheters

• ClinicalTrials.gov Identifier: NCT01287026
• Recruitment Status: Completed
• First Posted: February 1, 2011
• Last Update Posted: April 5, 2019
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information

• First Submitted Date: January 25, 2011
• First Posted Date: February 1, 2011
• Last Update Posted Date: April 5, 2019
• Study Start Date: February 23, 2011
• Actual Primary Completion Date: March 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 7, 2018)

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.

• Original Primary Outcome Measures (submitted: January 31, 2011): To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI-guidance and "passive" catheters

Current Secondary Outcome Measures (submitted: August 7, 2018)

• 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 ]
• To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans [ Time Frame: Ongoing ]

Original Secondary Outcome Measures (submitted: January 31, 2011)

• To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures
• To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Real-time MRI Right Heart Catheterization Using Passive Catheters
• Official Title: Real-Time MRI Right Heart Catheterization Using Passive Catheters

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.

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Caridovascular Disease
• Congenital Heart Disease
• Pulmonary Hypertension

• Intervention: Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)

Study Arms

Experimental: 1

Open Label

Intervention: Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)

• Publications *: Rogers T, Ratnayaka K, Khan JM, Stine A, Schenke WH, Grant LP, Mazal JR, Grant EK, Campbell-Washburn A, Hansen MS, Ramasawmy R, Herzka DA, Xue H, Kellman P, Faranesh AZ, Lederman RJ. CMR fluoroscopy right heart catheterization for cardiac output and pulmonary vascular resistance: results in 102 patients. J Cardiovasc Magn Reson. 2017 Jul 27;19(1):54. doi: 10.1186/s12968-017-0366-2.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 31, 2015): 150
• Original Estimated Enrollment (submitted: January 31, 2011): 20
• Actual Study Completion Date: March 21, 2019
• Actual Primary Completion Date: March 21, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 99 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01287026
• Other Study ID Numbers: 110091; 11-H-0091
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert J Lederman, M.D.; National Heart, Lung, and Blood Institute (NHLBI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: March 21, 2019