Trial record 2 of 20 for:    cardiac catheterization | Open Studies | NIH, U.S. Fed

Real-time MRI Right Heart Catheterization Using Passive Catheters

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01287026
First received: January 25, 2011
Last updated: June 28, 2014
Last verified: November 2013
  Purpose

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 Intervention Phase
Caridovascular Disease
Congenital Heart Disease
Pulmonary Hypertension
Device: Balloon catheter for right heart catheterization
Drug: Gadopentate Dimeglumine (Gadolinium); Contrast Agent
Procedure: Right Heart Catheterization
Procedure: Cardiac Real-time MRI
Procedure: Vascular Hemostasis
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Real-Time MRI Right Heart Catheterization Using Passive Catheters

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI-guidance and "passive" catheters

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

Estimated Enrollment: 100
Study Start Date: January 2011
Intervention Details:
    Device: Balloon catheter for right heart catheterization
    N/A
    Drug: Gadopentate Dimeglumine (Gadolinium); Contrast Agent
    N/A
    Procedure: Right Heart Catheterization
    N/A
    Procedure: Cardiac Real-time MRI
    N/A
    Procedure: Vascular Hemostasis
    N/A
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01287026

Contacts
Contact: Annette Stine, R.N. (301) 402-5558 stinea@nhlbi.nih.gov
Contact: Robert J Lederman, M.D. (301) 402-6769 lederman@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Robert J Lederman, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01287026     History of Changes
Other Study ID Numbers: 110091, 11-H-0091
Study First Received: January 25, 2011
Last Updated: June 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
MRI Catheterization
Right Heart Catheterization
Pulmonary Artery Catheterization
MRI Safety
Jugular Vein Catheterization
Heart Catheterization
Heart Disease
Cardiovascular Disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Contrast Media
Hemostatics
Diagnostic Uses of Chemicals
Pharmacologic Actions
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014