Real-time MRI Right Heart Catheterization Using Passive Catheters
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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 |
- To test the initial safety and feasibility of diagnostic right heart catheterization in human subjects using MRI-guidance and "passive" catheters
- 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: | 60 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
-
Device: Balloon catheter for right heart catheterization
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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.
Contacts and Locations| Contact: Annette Stine, R.N. | (301) 402-5558 | stinea@nhlbi.nih.gov |
| Contact: Robert J Lederman, M.D. | (301) 402-6769 | lederman@nih.gov |
| 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 | |
| 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, 2012 |
| 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 Hypertension Hypertension, Pulmonary Heart Defects, Congenital Cardiovascular Diseases Vascular Diseases Lung Diseases Respiratory Tract Diseases |
Cardiovascular Abnormalities Congenital Abnormalities Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 18, 2012
