A Phase 1/2 interventional study of Cardiac Real-time MRI RHC (Right Heart Catheterization) in Caridovascular Disease, Congenital Heart Disease and Pulmonary Hypertension, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to participants aged 2 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-04-05.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 1/2, Interventional, and Diagnostic
Background:
Objectives:
Eligibility:
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 150 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Open Label
Procedure: Cardiac Real-time MRI RHC (Right Heart Catheterization)
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.
Time frame: Ongoing
To train staff in the conduct of simple MRI catheterization in humans, to accrue incremental experience towards more complex MRI catheterization procedures
Time frame: Ongoing
To test incremental MRI scanning techniques (technical developments) to assist MRI catheterization in humans
Time frame: Ongoing
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI)