View Clinical Trial (Medical Research Study)
Real-Time MRI Right Heart Catheterization Using Passive Catheters
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Caridovascular Disease - Congenital Heart Disease - Pulmonary Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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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 will perform systematic right-sided heart
catheterization without X-ray whenever possible. We will use this protocol to further refine
the technique.
If successful, this will enable future adult and pediatric testing of MRI-guided
catheterization using special active wire guides, which may lead to new non-surgical
treatments of cardiovascular disease.
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| Criteria: |
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- INCLUSION CRITERIA:
Adult patients, age greater than or equal to 21
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:
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 MDRD 2005 revised study formula:
-eGFR (mL/min/1.73m(2)= 175 x standardized S(cr) (-1.154) x age(-0.203) x 0.742 (if the
subject is female) or x 1.212 (if the subject is black)(29)
Subjects meeting this exclusion criterion may still be included in the study but may not
be exposed to gadolinium-based contrast agents.
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| NCT ID: |
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NCT01287026 |
| Primary Contact: |
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Principal Investigator
Robert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Annette Stine, R.N.
Phone: (301) 402-5558
Email: stinea@nhlbi.nih.gov
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| Backup Contact: |
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Email: lederman@nih.gov
Robert J Lederman, M.D.
Phone: (301) 402-6769
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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