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Real-time MRI Right Heart Catheterization Using Passive Catheters

Primary Purpose

Caridovascular Disease, Congenital Heart Disease, Pulmonary Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cardiac Real-time MRI RHC (Right Heart Catheterization)

About this trial

This is an interventional diagnostic trial for Caridovascular Disease focused on measuring MRI Catheterization, Right Heart Catheterization, Pulmonary Artery Catheterization, MRI Safety, Jugular Vein Catheterization, Heart Catheterization, Heart Disease, Cardiovascular Disease

Eligibility Criteria

2 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Institutes of Health Clinical Center, 9000 Rockville Pike

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Open Label

Outcomes

Primary Outcome Measures

To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and

There will be no heating or adverse events related to the MRI RHC.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01287026

First Posted

January 25, 2011

Last Updated

April 3, 2019

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01287026

Brief Title

Real-time MRI Right Heart Catheterization Using Passive Catheters

Official Title

Real-Time MRI Right Heart Catheterization Using Passive Catheters

Study Type

Interventional

2. Study Status

Record Verification Date

March 21, 2019

Overall Recruitment Status

Completed

Study Start Date

February 23, 2011 (undefined)

Primary Completion Date

March 21, 2019 (Actual)

Study Completion Date

March 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Caridovascular Disease, Congenital Heart Disease, Pulmonary Hypertension

Keywords

MRI Catheterization, Right Heart Catheterization, Pulmonary Artery Catheterization, MRI Safety, Jugular Vein Catheterization, Heart Catheterization, Heart Disease, Cardiovascular Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Open Label

Intervention Type

Procedure

Intervention Name(s)

Cardiac Real-time MRI RHC (Right Heart Catheterization)

Primary Outcome Measure Information:

Title

To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI- guidance and

Description

There will be no heating or adverse events related to the MRI RHC.

Time Frame

Ongoing

Secondary Outcome Measure Information:

Title

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

Title

To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans

Time Frame

Ongoing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Lederman, M.D.

Organizational Affiliation

National Heart, Lung, and Blood Institute (NHLBI)

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center, 9000 Rockville Pike

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28750642

Citation

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.

Results Reference

derived

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Real-time MRI Right Heart Catheterization Using Passive Catheters

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