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| ID | Type | Description | Link |
|---|---|---|---|
| Internal Bridge funding | Other Identifier | Children's Research Institute, Children's National |
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Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI guided cardiac catheterization | Experimental | Magnetic resonance imaging will be used to guide cardiac catheterization procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI guided cardiac catheterization | Procedure | Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| Test the feasibility of navigating catheters into right heart structures using real-time MRI | Heart catheterization usually uses X-ray guidance. Using commercially available MRI-compatible catheters, the right heart catheterization procedure will be done using real-time magnetic resonance imaging (MRI). MRI guidance does not use X-ray radiation. | At the end of each catheterization procedure through study completion,up to 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants whose MRI cardiac catheterization procedure was prematurely terminated | Premature termination will occur under the following circumstances:
|
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Inclusion Criteria:
Exclusion Criteria:
Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
Women who are pregnant
Women who are nursing and who do not plan to discard breast milk for 24 hours
Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:
Exclusion criteria for Gadolinium (contrast agent)
1. Renal disease with estimated glomerular filtration rate < 30 ml/min/1.73 m2 body surface area
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Kanter, MD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19909937 | Background | Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. doi: 10.1016/j.jcmg.2009.09.002. | |
| 19114017 | Background | Ratnayaka K, Faranesh AZ, Guttman MA, Kocaturk O, Saikus CE, Lederman RJ. Interventional cardiovascular magnetic resonance: still tantalizing. J Cardiovasc Magn Reson. 2008 Dec 29;10(1):62. doi: 10.1186/1532-429X-10-62. |
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| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| D009202 | Cardiomyopathies |
| D006344 | Heart Septal Defects, Atrial |
| D001024 | Aortic Valve Stenosis |
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Magnetic resonance imaging | Device |
|
| At the end of each catheterization procedure through study completion,up to 5 years |
| Measurement of radiation exposure | Comparison of radiation exposure in this cohort of subjects to historical controls undergoing matched invasive cardiology procedure at CNMC. | End of study, 5 years. |
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| 28874164 | Derived | Ratnayaka K, Kanter JP, Faranesh AZ, Grant EK, Olivieri LJ, Cross RR, Cronin IF, Hamann KS, Campbell-Washburn AE, O'Brien KJ, Rogers T, Hansen MS, Lederman RJ. Radiation-free CMR diagnostic heart catheterization in children. J Cardiovasc Magn Reson. 2017 Sep 6;19(1):65. doi: 10.1186/s12968-017-0374-2. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006343 | Heart Septal Defects |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |