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| ID | Type | Description | Link |
|---|---|---|---|
| 11-H-0091 |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Open Label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Real-time MRI RHC (Right Heart Catheterization) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Ongoing |
| Measure | Description | Time Frame |
|---|---|---|
| To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures | Ongoing | |
| To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans |
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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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28750642 | Derived | 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006976 | Hypertension, Pulmonary |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008171 | Lung Diseases |
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| Ongoing |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |